Thu December 5, 2013
How A Recalled Medical Device Killed A Vet At Seattle's VA Hospital
Editor’s note 2/7/2014: This story has been edited to remove references to VA officials’ incorrect claim that a Seattle VA nurse saw the Infusomat recall at the FDA website in March 2012. While manufacturer B. Braun sent the VA and other customers its recall notice in March, FDA did not post information about the manufacturer’s March 23, 2012, recall letter until August 1. The story has also been edited to attribute to medical records the statement that, the night Eddie Creed died, a doctor asked his sister if she wanted an autopsy to be done. Creed's sister claims the VA never asked her about an autopsy. The content in the edited story differs from the audio in the original broadcast.
When Eddie Creed, a Seattle jazz musician, died at the Veterans Affairs hospital on Beacon Hill last year, his death certificate said throat cancer had killed him.
But a KUOW investigation reveals what his doctors knew: A medical device called an Infusomat, which had been recalled the month before, ended his life. Still, nobody knows why.
The week the device was recalled, a trainer for B. Braun, the German manufacturer that produced it, came to the Seattle VA to teach nurses how to use the machine. According to the nurses, the trainer told them that a correction was coming soon for the device’s breakable plastic clip, but it was safe to use the machines until they were repaired. So the VA started using the Infusomats despite the "urgent medical correction letter" B. Braun sent its customers.
That recall was the most serious kind – a "Class I" recall. Class I doesn't mean the product has to be pulled right away, but it does mean someone could die or be seriously harmed if the recall is ignored. The manufacturer said that improperly loading the Infusomat could lead to an uncontrolled flow of drugs. So could closing its door too hard and breaking a small plastic clip inside.
So far as anyone can tell, none of those problems happened with the Infusomat hooked up to Creed. But the machine malfunctioned anyway, draining all its morphine into Creed – three weeks after the recall.
VA officials in Seattle say they never received the recall letter. B. Braun had sent it to the Department of Veterans Affairs' central office in Washington, D.C., where most recall notices go, according to VA Puget Sound Chief of Staff William Campbell.
Jason Ford, the US spokesman for B. Braun, a manufacturer with more than $6 billion in annual revenue, declined to be interviewed or answer questions for this story.
‘Not very confidence inspiring’
When Creed was in the Army in the 1950s, he directed a choir and played trombone in a marching band. Later, he played piano for Seattle’s Chamber Jazz Quartet.
“When he would play the piano, it just melted my heart and made me so proud of him,” said Sherry Evard, his partner of several years.
Creed was 77 when he died at the VA hospital. He had been struggling with throat cancer and went to the VA for end-of-life care in April 2012.
"The last time I saw Eddie was the night that he died, and as I left him, I kissed his forehead and said, 'I love you,'” Evard said. “I had no idea that he was going to die that night, or I would have stayed."
On his first day at the hospital, nurses hooked him up to a morphine drip for his pain. Evard said the nurses appeared to have trouble setting it up.
"They seemed concerned about how to get it started and a bit uncertain, maybe, that it was administering the morphine properly," she said. But to the nurses' credit, she said, they double-checked before they left.
"After they left, I said to Eddie, 'That was not very confidence inspiring, was it?'” she said. “He just simply said, 'No.'"
The Infusomat, a machine the size of a phone book, is designed to send precise volumes of liquid from a hanging plastic pouch into a patient’s IV line. B. Braun's training materials emphasize safety and avoiding the danger of "free flow" — that's drugs pouring out, uncontrolled.
According to a B. Braun training video: "Clinicians must be vigilant to be certain they are using the technology as intended to achieve the maximum safety afforded by the technology."
But on Creed's second night at the VA, something went wrong and the morphine flowed freely while he was asleep. Around 11 p.m., a nurse found a drained pouch of morphine hanging above his bed. Creed had received about 10 times the dose he was prescribed. He was pronounced dead minutes later.
Recalls of medical devices rarely make headlines. But over the past decade, the US Food and Drug Administration has seen a "dramatic increase" in the number of recalls affecting infusion pumps.
"Sadly, we actually have much more access to information about defective toasters, and certainly defective cars, than we seem to about defective medical devices," said Diana Zuckerman, who heads the National Research Center for Women and Families in Washington, D.C. The nonprofit focuses on medical-device safety.
Manufacturers are required to notify their customers of the recalls. Often, Zuckerman said, the medical-device recall notice doesn't reach the right hospital department or doctor.
"There's a lot of ways that the information may not get to the right person in a timely manner,” she said. “In some cases, devices continue to get used that should have not been used at all any more because they're so dangerous."
The FDA doesn't say how quickly a hospital must act on a manufacturer's recall, even a Class I recall. The VA’s Campbell said the VA handled this recall properly.
"This specific recall was something that needed to be scheduled in a timely manner, but it didn't need to be done that day, and there was no need to remove pumps from circulation,” he said. “If that had been communicated, we would've done that without hesitation."
The night that Creed died, the VA hospital set his Infusomat aside to investigate what went wrong. VA staff couldn't find anything, so they brought in medical-device experts from the ECRI Institute in Pennsylvania. ECRI, an independent nonprofit, is listed as a federal patient safety organization by the US Department of Health and Human Services and accepts no funding from the medical-device or pharmaceutical industries.
"They did not find evidence of user error from the programming,” Campbell said. “They were not able to produce the free flow, either."
In other words, the VA and the outside experts tried to make fluids flow freely out of the electronic pump again — as the morphine had flowed into Creed — but couldn't. They also ruled out anyone misusing or tampering with the pump.
“A clip had not broken,” Campbell said. “When we first pulled the pump out of circulation, that was one of first things that was looked at, and the clip was intact."
Doctors Don’t Indicate Accident
Why Creed died that night remains a mystery. Would quicker action on the recall have spared his life that night? Or would a newly repaired pump have had the exact same problem? There's no way to know.
But Evard wishes doctors had been more immediately forthcoming with her about his death.
The night Creed died, a VA doctor telephoned Creed's sister and Evard with the bad news. According to VA medical records, he asked if they wanted an autopsy to be done. They had no idea there had been a medical accident. They said no.
"A doctor called me and informed me that Eddie had passed away, but he did not indicate that an accident had happened," Evard said.
Creed's loved ones were informed of the accident the next day. But they were not asked again whether they wanted an autopsy.
Campbell acknowledged that seemed “a bit out of sequence,” because Creed's loved ones wouldn't be able to make an informed decision. Campbell said the VA could examine how that happened. But one thing they can’t do now, or ever, is an autopsy. Creed was cremated five days after he died.
The VA investigated the accident almost immediately and brought in outside investigators as well. The hospital only released the findings to Creed's loved ones in the past two weeks – after KUOW first reported events leading to Creed’s death.
The VA also did not report the accident to the county medical examiner as required by state law.
"We're required to investigate any drug overdose or complication of therapy. Something goes wrong in surgery, a hospital reports that to us and we take jurisdiction," Greg Hewett of the King County Medical Examiner's Office said. "That wasn't reported to us in this case."
After KUOW brought the erroneous death certificate to the VA's attention, VA Puget Sound officials issued a statement. It acknowledged the morphine accident as the main cause of Creed's death. It blamed an internal communication error and said the VA is reviewing its policies to make sure such an error is not repeated.
VA officials said they reported the accident to the FDA. Such reports wind up in a national database of medical equipment accidents. The data is available to the public, but it is scrubbed of all identifying information – not just of patients or doctors involved, but of the hospitals as well.
"I think the important point here is there was no attempt to cover anything up. We were very open with the family from the get-go about the morphine over-infusion," Campbell said.
Thousands Harmed By Medical Devices
Creed was just one of thousands of patients harmed by a malfunctioning medical device in the US every year. Finding out how or even where those events happened can be an uphill climb for families or others interested in hospital safety, particularly for those whose loved ones are patients at the VA.
If a malfunctioning device harms a patient at almost any hospital in Washington state, it has to be reported to the state health department. Those mishaps appear on a website the state has set up to provide more transparency around hospital safety.
VA hospitals and state-run psychiatric hospitals are the only ones exempt from that requirement.
As part of an agency-wide push for more transparency, the Department of Veterans Affairs does put a lot of information online about its hospitals, including various measures of the quality of care the hospitals provide.
But the VA shares little about its medical mishaps.
Other hospitals in Washington state must publicly disclose 29 different kinds of mishaps any time they occur. VA hospitals only reveal four types of mishaps. Those four mishaps don’t include what killed Creed: a medication error. The only way to learn about those at a VA hospital is if an individual involved comes forward, as Evard did to KUOW.
Infusomat: One-Star Rating
A December 2012 review from the ECRI journal Health Devices gave the Infusomat a one-star rating, lowest of the six drug pumps reviewed. With its general difficulty of use and risk of life-threatening free flow, the Infusomat "should be avoided," according to the nonprofit journal's reviewers.
Medication errors aren't limited to any one brand. According to the latest numbers available from the FDA, the agency gets about 10,000 reports a year of infusion pump problems. About 120 people die each year and 3,800 suffer serious injuries from pump malfunctions.
National medical organizations started warning of the risk of drugs pouring uncontrolled out of infusion pumps more than a decade before that exact thing killed Creed.
"Eliminate the use of IV pumps and administration sets that are unnecessarily hazardous when alternatives exist," the VA's own National Center for Patient Safety advised in 2002.
In 2010, the FDA concluded that infusion pumps have resulted in “numerous, systemic problems with device design, manufacturing, and adverse event reporting.”
That year, the FDA started an infusion pump safety initiative. Three years later, the agency is still drafting voluntary guidelines for companies to use in manufacturing safer pumps.
FDA spokeswoman Morgan Liscinsky declined to answer questions about the safety initiative, other than to state that most manufacturers are following the draft guidelines.
In November, ECRI Institute, the medical-device research group hired by the VA to investigate Creed's accidental overdose, called infusion pumps the nation's number-two medical-technology safety hazard. They came in second only to an excessive din of medical alerts causing alarm fatigue in hospitals.
According to FDA watchdogs, the problems don't stop at drug pumps. More than 90 percent of all new medical devices are cleared by the FDA without being clinically tested on humans.
"Implants and infusion pumps aren't held to the same standards as a medication for tummy aches," Zuckerman said. "If you're a company, and you're making a new infusion pump, all you have to do is paperwork that you say is evidence your new kind of infusion pump is substantially similar to another infusion pump that's already on the market. It might be that infusion pump has never been proven safe or effective either."
The FDA will even okay a new device if it's similar to another device that's been recalled. Legislation to close that loophole died in Congress last year.
The Institute of Medicine, the health arm of the National Academy of Sciences, said in 2011 that the FDA's screening of new medical devices was unreliable and the process needed to be scrapped entirely.
Medical device industry lobbying groups didn't respond to requests for comment. But the website of the Advanced Medical Technology Association praises the current FDA system, saying it “has a remarkable 30-year track record of protecting the public health while making safe and effective products available without unnecessary delays."
As for the Infusomats at the Seattle VA, they were taken out of service two weeks after Creed died and moved to a warehouse where they’ve been sitting unused since. That's $1.9 million of medical equipment the VA isn't using because of Creed's death. The VA returned to the older pumps the Infusomats were meant to replace.
"We're all frustrated about not having a definitive answer,” Campbell said. “It prompted us to remove the pumps from service, and we're comfortable having done that, but we really would like to know exactly what it was that happened. So I understand Mr. Creed's loved ones' frustration with this; we share that frustration."
VA Puget Sound hasn't taken any concrete steps to return the Infusomats or recover any costs from B. Braun. VA officials said they haven't decided how to proceed.
Searching For Answers