The patient was receiving morphine as part of his cancer treatment and the nurse hooked him up to a morphine drip for pain.  The Infusomat device from B. Braun was the device that malfunctionedimage and dispensed not a drip but the entire contents of the bag and he received 10 times the amount of what he was supposed to have had.  The device has missed being taken out of circulation for use.  It was a class one recall from the FDA. It was not the software they said in the investigation and they were not able to duplicate the malfunctions, so it appears we are left with a case of a rogue algorithm in the software.  You hear about those in trading software but they really are everywhere and you never know. 

Scroll on down and watch video #4 in the footer here and Kevin Slavin gives you an example of an Amazon rogue algorithm to where it keep increasing the price of a book about flies until it hit over a million in price and it was all the algorithm functioning on it’s own, so that might be what we have here.  If you can as a developer or programmer recreate the scenario that’s kind of the assumption you are left with, rogue. 

Granted he was being given end of life care and was not expected to survive for a long length of time, but what if this had occurred with a patient not near the end of life, that is the concern with the device being used in other situations.  

The FDA did release rules for Bar Codes on medical devices in September and you can read more on that topic at the link below. 

FDA Releases Rules for Bar Codes on Medical Devices–Lot of History on That Discussion in the Archives of the Medical Quack Summarized Here

Below is a published article I wrote about this topic a couple years ago and I keep it in the right hand column here to read as well.  I try to cover as a blogger important recalls but I didn’t see this one either, but it was there but I missed it for reporting on this blog too, so again we come back to needing those bar codes and I have an archived page here you can read with more links on the topic.  Some of the technologies have been updated and changed but the basic scanning with a cell phone or device is still there.  BD

Micro-Cap FDA Recalls Never End


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" posted at FDA.gov.

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.

I had no idea that he was going to die that night, or I would have stayed.

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. He said a Seattle VA nurse saw the urgent, Class I recall on the FDA's website a few days after the recall was issued.

http://kuow.org/post/how-recalled-medical-device-killed-vet-seattles-va-hospital

0 comments :

Post a Comment

 
Top