Recalled Pain Pump Caused Overdose Death: Who Was Responsible?

Recalled Pain Pump Caused Overdose Death: Who Was Responsible?

In April 2012, a 77-year-old Seattle musician and U.S. Army veteran died at a VA hospital after a long struggle with throat cancer. He had come to the hospital for end-of-life care but, tragically, it wasn’t his cancer that killed him. He died on his second night in the hospital from a massive morphine overdose. An Infusomat pain medication pump attached to his IV had failed somehow, allowing the drug to flow uncontrolled into his veins.

A month before his death, the U.S. Food and Drug Administration had issued a Class I recall on the Infusomat and posted an “urgent medical correction letter” on FDA.gov. A Class I medical device recall indicates a serious risk of injury or death, and there were problems with the Infusomat that could allow the uncontrolled flow of drugs. In this patient’s case, however, none of reported issues appears to have been responsible.

A tragic series of missteps, mistakes and miscommunications surrounded the vet’s death, prompting a local public radio station to investigate. More than a year later, however, there’s still no clear answer as to whether the Infusomat’s manufacturer, the hospital, medical staff or another issue was responsible.

The possibilities include, at the very least: inadequate training of nurses on the use of the pump; the device being unusually difficult to operate; misdirection of the recall notice; and a misinterpretation of the urgency of the recall. Unfortunately, the cause of death was also incorrectly reported to state health authorities, so no autopsy was performed. The man’s remains have been cremated.

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We do know that pain pump malfunctions allowing uncontrolled medication flow and posing a substantial risk of patient injury or death have been reported for at least a decade. The FDA receives around 10,000 malfunction reports annually, and estimates that 3,800 people suffer serious injuries and 120 die every year from pain pump defects.

The medical-device research group ECRI Institute calls pain pumps the nation’s No. 2 safety hazard among all medical technologies. The reporters also noted serious problems with the FDA’s medical device approval process, particularly when it comes to pain infusion pumps.

All of the Seattle VA’s Infusomats are now out of service, but the mystery of this vet’s exact cause of death remains. What we know for sure is that this was only one in a long series of tragedies faced by families across the nation.

Source: KUOW News and Information, “How A Recalled Medical Device Killed A Vet At Seattle’s VA Hospital,” John Ryan, Dec. 5, 2013

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