The QMN Weekly Bulletin
Sept. 21, 2012 | Vol. 4 No. 38
Smiths Recalls Infusion Pump for Software Woes
Smiths Medical Medfusion 4000 syringe infusion pumps are being recalled due to a software problem. A system error could cause the pump to stop running, potentially ending patient therapy and causing an adverse event.
No injuries or deaths were reported. Smiths said upgrades to the pumps software are complete in the U.S. and underway in Canada. The Class I recall of pumps’ distributed between Sept. 10, 2010, and Feb. 3, 2012, was initiated by the company.
A recent FDA report found 25 percent of all recalled devices were the result of bad software. If your product has embedded software — or is connected via a network — you now have a 1 in 4 chance of a recall.
FDAnews’ Tuesday webinar, Medical Device Software Recalls on the Rise What’s Causing Them, What the FDA is Doing About Them, and What Manufacturers Should Do to Prevent Them won’t be a regurgitation of regulations; it will be a study of what is failing in the software industry, why those failures are not detected during product development, and what can be done to improve the situation.
You and your colleagues will participate from the comfort of your own office, conference room or auditorium. No planes, no hotels — just 90 minutes of solid, interactive learning. Register today!
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