A week before surgery on Thanksgiving Day 1997, Dorothy Brenia placed a roast turkey on the dining room table, picked at a few pieces of meat, then softly told her husband and son that she feared this would be her last family dinner.
The 66-year-old retired schoolteacher’s premonition proved tragically correct. But death did not come from the swollen artery near her heart, or from complications in surgery to remove the aneurysm.
It came at the hands of a Florida nurse who committed a basic error, overdosing Brenia while working an infusion pump, a common piece of hospital equipment that can be deadly if improperly used.
Brenia is just one casualty of nurse error and imperfect technology. Since 1995, registered nurses have fatally overdosed 39 patients and injured 373 others while handling infusion pumps capable of delivering rapid, uncontrolled bursts of medicine through intravenous lines, a Tribune investigation has found.
In each of these cases, a nurse switched off the pump but failed to manually engage a small roller clamp on the IV line, which stops the flow of medicine, state and federal health-care records show.
Health-care investigators have a name for this silent killer: free flow.
Virtually all hospitals rely on the shoebox-size infusion pumps to regulate the flow of medicine and liquids into patients’ bodies, from potentially deadly morphine painkillers to non-toxic saline solutions.
Infusion pumps, which almost always are operated by nurses, have been linked to more than a thousand deaths over the last decade, government records indicate. The causes range from nurse errors, such as punching in the wrong amount of medicine, to machine malfunction.
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The free-flow deaths associated with the pumps are especially vexing because they are so easily preventable.
Nurses who are properly trained and who are not overwhelmed by other duties should be able to use the pumps safely, health-care experts said. Training for the pumps ranges from less than an hour to half a day.
Most infusion pumps are built with fail-safe mechanisms that automatically halt the flow of fluids, a feature known as free-flow protection. The pump will prevent an overdose if a nurse neglects to close the roller clamp.
Still, hospitals often opt for the more error-prone models, which often are cheaper to operate. At least 150,000 infusion pumps–one in every four used by hospitals today–are capable of free flow, either because they lack safety devices or those devices can be dismantled.
Few of these models are labeled so that nurses know which kind they are using, a Tribune analysis of manufacturing and hospital purchasing records shows.
For more than a decade, federal regulators have quietly documented the relationship between nursing errors and older-model infusion pumps. But for just as long, they have maintained there is no substantial public danger and have done little to reduce the chance of free-flow errors.
The many deaths and errors associated with the machines is another troubling sign of the mounting crisis in nursing today–a crisis fueled by hospital cutbacks in staffing and training as well as financial pressures that encourage hospital administrators to use pumps lacking inexpensive automatic safety features.
“What we have are machines that are not safe,” said Hedy Cohen, a nationally recognized training expert and registered nurse at the Institute for Safe Medication Practices, a research and advocacy group based in Warminster, Pa. “To compound that, we have nurses who are overworked, overstressed and have too little education.
“Hospitals are putting profits ahead of safety,” she said.
Infusion pumps gained prominence in the early 1990s as an improvement over the less precise gravity-fed system in which medicine slowly dripped from bags hung from poles.
With the gravity system, nurses spent more time with patients, visually calculating medicine flow with wristwatches. Today, many nurses acknowledge that they dash into patients’ rooms, quickly enter dosage levels on the infusion pump’s keyboard, then rush off to help other patients.
The pump snaps on to an IV line and regulates the flow of medicine entering a patient’s body. The potential for dangerous free flow occurs when the pump is shut down and the IV line is detached from the machine. Gravity can then pull all the medication through the line and into the patient.
If a nurse engages the roller clamp that is attached to the IV, there can be no free flow. In addition, later-model pumps include safety features that can stop the flow of medicine even if the clamp isn’t closed.
But many of the older-model pumps, which don’t provide this added layer of protection, are still in use–making free flow a continuing threat to patient safety.
The U.S. Food and Drug Administration has recommended that pumps enabling free flow be identified by hospitals with warning stickers, but that suggestion is widely ignored. Furthermore, nurses are not always trained about the dangers of using pumps capable of free flow.
More than two dozen registered nurses at the University of Illinois at Chicago Medical Center said they were surprised when another nurse informed them that pumps capable of free flow are used in the hospital alongside newer models.
“There is no way to tell one pump from another,” said registered nurse Opal Brown.
UIC declined to comment on the types of pumps it is using.
Some hospitals also use pumps with safety features that can be disabled, which makes free flow more likely.
For example, the Flo-Gard 6201–made by Baxter International Inc. of Deerfield, beginning in 1994 but no longer manufactured–includes a clip that automatically stops free flow even if the roller clamp on the IV is not engaged. But the instruction manual for the Flo-Gard 6201 illustrates how to use it without this safety clip.
ECRI, a nonprofit research institute in Pennsylvania that focuses on medical errors, rates any machine that is capable of free flow, including those where safety mechanisms can be disconnected, as potentially dangerous.
Among them are the Flo-Gard 6201, three other Baxter models and two models from another Chicago-area firm, Abbott Laboratories. All these pumps no longer are manufactured but remain in use in hospitals.
Why would a hospital want to disconnect a safety feature? It can save money.
The primary cost of operating a pump usually is not in the machine, which the manufacturer sometimes supplies for free, but in the replacement of tubing. Pumps with free-flow protection use slightly more expensive IV tubing. The cost difference is compounded because IV tubing must be replaced frequently.
Even the difference of a few pennies can add up to thousands of dollars in savings.
Baxter officials said they encourage hospitals to upgrade to the latest models, but company officials said they believe hospitals shoulder the responsibility for what type of equipment is used and whether to disconnect any features.
Manufacturers say the pumps are not defective and free flow cannot occur unless a nurse makes a mistake.
Baxter International sends out roving teams of 100 registered nurses who hold sessions explaining the machines. Abbott officials said they offer extensive nurse training on all their models.
Mark E. Bruley, an ECRI vice president, agreed that nurse training is critical. He said any shortcomings with the machine’s design are exacerbated when nurses are unfamiliar with the nuances of the pumps and are overburdened with numerous tasks.
“One could easily envisage that overworked nurses get to the point where they physically can’t accept any more input on what’s going on around them,” Bruley said. “Attention is diverted for a split second and a mistake is made.”
An early warning
Free flow is so devastating because it happens quickly and silently.
An accident in February 1988 involving a California woman pregnant with twins was among the earliest signs of an emerging pattern of nursing errors linked to free flow, files from the U.S. Food and Drug Administration show.
A registered nurse disconnected an infusion pump, but failed to engage the roller clamp that would keep the medicine from flowing into the patient. The nurse later explained that she was rushing because the hospital was short-staffed and admitted that she was unaware free flow could be so rapid, according to an investigative report prepared for the FDA.
Within seconds of switching off the pump, a surge of magnesium sulfate–an anti-inflammatory medicine used to relax muscles–coursed into the 33-year-old patient’s bloodstream, resulting in a heart attack.
The twins survived, but the mother died the same day, according to FDA records, which do not name the victim or the hospital.
In 1992, a pregnant New York woman–also not named in federal records–was the victim of free flow involving an overdose of Pitocin, a labor-inducing drug.
While the mother was being transferred to the delivery room, an untrained nurse aide removed the infusion pump–once again without engaging the roller clamp to the intravenous line. The mother received nearly 35 times the prescribed amount of Pitocin.
The mother survived, but the infant suffered organ damage and died four days later.
Descriptions of these free-flow accidents and others are found in a variety of public records. Under the federal government’s voluntary system of reporting errors, however, hospitals provide only scant information, and the records seldom disclose identifying details involving patients or facilities.
Federal reports linked to human error and free flow include these incidents:
Aug. 31, 1994: “Allegedly, a nurse removed the tubing from the pump without closing the roller clamp. This resulted in the PT [patient] experiencing cardiac arrest and additional complications. The head nurse commented that the device was functioning correctly and free flow was due to nursing error.”
Feb. 13, 1997: “Elderly male PT . . . entire amount infused in approximately one hour. The PT experienced respiratory difficulty.”
Nov. 19, 1998: “PT death . . . PT was being infused with pain relieving drug … dose that was set to take 24 hours to inject was given over a 10 to 20 minute period.”
Despite these cases, as well as hundreds of other injuries and deaths, and despite concerns raised by influential health-care organizations about the infusion pumps over many years, the FDA has done little to curtail use of the error-prone machines.
As hospitals restock with newer, safer pumps, the FDA estimates that in five to eight years, few of the more dangerous pumps will still be in use.
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In a two-page public health advisory in 1994, agency officials recommended placing adhesive warning stickers on pumps capable of free flow. The same advisory stopped short of a recall or a ban on the pumps; instead it encouraged hospitals to phase out pumps capable of free flow.
“We don’t regulate the practice of medicine,” said Sharon Schneider, an FDA spokeswoman.
In a July 1999 letter responding to concerns about free-flow pumps, an FDA official wrote to U.S. Sen. Bob Graham (D-Fla.), saying there was insufficient evidence that the public was endangered. Graham had inquired about a recall on behalf of the Brenia family.
By the FDA’s calculations, Brenia’s death is statistically insignificant. Schneider said the Tribune’s numbers on deaths and injuries linked to free flow are only meaningful if balanced against the “denominator” of how often pumps are used in every hospital, every day. Under that standard, less than 1 millionth of one percent of infusion-pump uses result in a free-flow accident, FDA files show.
Other federal agencies, though, react more aggressively when a cluster of deaths is linked to machines or equipment. The government pushed for recall of defective Firestone tires after they were linked to 88 deaths, and reforms quickly followed in the wake of 43 child deaths from passenger-side airbags.
Although the FDA “has received reports of injuries and deaths from uncontrolled, rapid infusion of medications,” no action is necessary, wrote Melinda K. Plaisier, FDA interim associate commissioner for legislative affairs, in a July 1999 letter to Graham.
“Currently,” she wrote, “the FDA does not have adequate evidence on the prevalence of free-flow accidents compared to the large number of infusion pumps that are being used in the market today to warrant an action.”
Officials at ECRI, which helps the FDA investigate medical errors, have warned about infusion pumps capable of free flow for more than a decade. They contend that the federal government should require all pumps capable of free flow to be immediately replaced.
“Given the wealth of evidence over decades of study, there is no reason for any hospital to use infusion pumps capable of free flow,” said ECRI’s Bruley.
The Institute for Safe Medication Practices sent a letter to every U.S. hospital–6,000 letters in all–urging removal of unsafe pumps in 1998, an action that apparently has had only a minor impact.
Some hospitals, however, already had acted before receiving the letter. For instance, based on nursing staff concerns about patient safety, the University of Chicago Hospitals in 1996 banned the use of infusion pumps lacking free-flow protection.
The evidence was overwhelming, spokesman John Easton said, that the older pumps represented an unnecessary, potential danger.
`Don’t worry, Mom’
The aneurysm in Dorothy Brenia’s stomach began as an unnoticeable, minor swelling of a blood-rich artery that led away from the heart.
But it doubled in size over 10 years to 6.5 centimeters by 1997, and her doctor, Aziz M. Al’Kafaji, recommended surgery. “You’re a time bomb waiting to explode,” he told the Hudson, Fla., woman.
Surgery always spikes a patient’s blood pressure, which already was high for Brenia. To prevent a dangerous rise, sodium nitroprusside was used to reduce Brenia’s blood pressure during the morning operation (this sentence as published has been corrected in this text). The drug is highly potent and delivered in small doses.
After surgery on Dec. 3, 1997, in the recovery room at Community Hospital of New Port Richey, Brenia regained consciousness and chattered happily about surviving the ordeal. She had prepared a living will for fear that she would end up brain dead, internal hospital records show.
Her care was assigned to registered nurse Janice Bennett, 58. She had been working at the hospital for 25 years and as a nurse since 1962 with a spotless record, according to state licensing records.
Before transferring Brenia to another floor, Bennett disconnected the infusion pump from the IV line so that the machine would not end up in another department, internal hospital records show.
The plan was to reconnect a different infusion pump to Brenia once she arrived at her destination.
Federal records show that at least 100 free-flow accidents have occurred when nurses removed pumps from patients who were transferred to another area of the hospital. Pumps should always stay with the patient, health-care risk managers advise.
Before removing the pump, Bennett was supposed to shut off the IV line manually with the roller clamp, a routine-though-vital safety procedure taught almost from the first day of nursing school. She later told authorities that she might have forgotten about the clamp, an inadvertent slip during a hectic day.
Within minutes of the mistake, a deadly dose of blood-thinning medicine coursed into Brenia’s bloodstream, internal hospital records show.
Bennett later said in a deposition that she did not realize her patient was dying before her eyes, a victim of stunningly quick and silent free flow.
In the hallway that day, Steve Brenia, 65, watched as his wife was wheeled past him, an IV pole and bag of medicine by her side. She looked groggy or sleepy. She was silent, he said, but her eyes were open and stared up at him, a tear rolling out of her right eye.
“I thought it might be a tear of happiness,” he said. “I didn’t know that she was being overdosed at that very moment.”
He stayed in the small waiting room with his son Alan, who had left work from another hospital where he was a pharmacist. Alan Brenia, 41, felt a disquieting chill when hearing his mother’s doctor summoned on the intercom to an emergency.
Within the hour, the doctor came to him and said, “There’s been a problem.”
His mother was in a deep coma. Doctors told him there had been an overinfusion of medicine, and they promised a full investigation.
Brenia was haunted by his words to his mother just the day before: “Don’t worry, Mom. I’m a doctor. Everything will be OK.”
By the time father and son were allowed into the intensive care area, they barely recognized her unconscious, swollen form.
Steve Brenia said he recalls running from the room. “I just couldn’t take it,” he said.
The blood-thinning drug gradually destroyed the lungs, kidney and heart, then caused the brain to swell so much that it pushed against the spinal cord. She was brain dead after four days.
Alan Brenia, flanked by his two brothers, held his mother’s hand as the respirator was turned off. He had promised he would be there.
“I did the most difficult task I have ever undertaken in my life,” he said.
Bennett, who lives in New Port Richey, said she does not want to discuss the case. In a deposition, she said, “As far as I know, this is the only time I’ve had a patient that has suffered this type of injury or outcome and I’m not about to go through it again with anybody else.
“I’ve resigned since this incident and I do not wish to put anybody else or myself in this position again, so I’ve left the field.”
The hospital admitted full liability after the Brenia family filed a malpractice suit. Under Florida law, liability is capped at $250,000.
Hospital administrators declined to comment on the case or disclose what models of infusion pumps it still uses.
According to health-care regulatory sources, Bennett had been using a Flo-Gard 6201 infusion pump in which the free-flow protection had been disabled. Had the safety protection been in use, it likely would have prevented free flow even if a nurse forgot to shut the roller clamp on the IV.
Baxter officials said their records state that the hospital had purchased Baxter models, but they said they are unsure if the 6201 model was used in Brenia’s care.
Investigators contracted by the federal government were unable to determine if the machine’s safety feature was disabled at the hospital or before the hospital bought the machine.
For Alan Brenia, the pain of his mother’s death is compounded by the knowledge that it could have been easily avoided.
“Nurses are using infusion pumps every day,” Brenia said. “But when the safety features are absent and a nurse makes even a small mistake, the effect to patients can be instantaneous and lethal.”
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Tuesday: Illinois rarely punishes nurses for fatal mistakes.
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