The devices are used on a 24 hour a day basis for patients with life-threatening kidney disease to keep fluid levels even. This is not a big recall unless it is you or someone you know depending on this device. As with many of devices today, the problem lies in software and an update is being issued.
We come back around to users overriding an alarm and continue the therapy, which could result in either too much or too little fluid. The software alert when changed will only allow a patient to override the settings no more than 5 times in 20 minutes. There could be something like a kink in the line that would cause this and the user may not see or understand that a kink or perhaps a clamp needs attention and focuses on bypassing the settings with an over ride. In having written software myself and trying to anticipate every move or change a user can make is difficult. The FDA has a page but there is no information as now available but will be posted when available. BD
Irvine-based Edwards Lifesciences Corp. is working with its former parent on the recall of a medical device that traded hands between the pair last year.
The Food and Drug Administration said Friday that it recalled the Aquarius Hemodialysis system, which is owned and distributed by Baxter International Inc.
Regulators said they issued a Class I recall, its most severe action, after reports of clinically significant fluid imbalance and the potential for patients to repeatedly override an imbalance alarm.
The FDA said that could result in serious injuries or death because of a decrease or increase in circulating blood.
Baxter, based in the Chicago area, said the recall affected fewer than 150 units, and that it would put in a software update to solve the problem at the end of the current quarter.
Edwards sold Aquarius and other devices that help patients with malfunctioning kidneys to Baxter last year for $65 million as part of Edwards' focus on its mainstay heart valves.
Orange County Business Journal Online
0 comments :
Post a Comment