Hospital infusion pump recall: Medley Pump / Alaris Pump model 8100

By Harvey Kirk
Posted January 12, 2008

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Cardinal Health has issued a nationwide Alaris Infusion Pump recall for model 8100, which was previously known as the Medley Pump. The hospital infusion pumps are used to deliver controlled amounts of medication or other fluid. Due to manufacturing defects, the devices could deliver too much of the prescribed fluid, potentially resulting in a serious or fatal injury.

The Alaris/Medley infusion pumps are often used in hospitals or other medical facilities through an IV (intravenous), IA (intr-arterial) or epidural. The hospital infusion pumps were distributed to facilities throughout the United States, and the recall applies to over 200,000 devices worldwide.

The hospital infusion pump recall was issued because the Alaris pumps could contain misassembled occluder springs, which is used to control the flow of medication. The springs could be bent, broken, nested or missing, which may result in too much medication or fluid being delivered. The FDA has classified the action as a Class 1 recall, since use of the defective Alaris/Medley infusion pumps involve a reasonable probability of serious injury or death.

Overinfusion is difficult for the hospital or medical provider to detect. The defective infusion pump springs could work intermittently, and there is no warning or alert that the device is delivering too much of the fluid.

Cardinal Health issued the infusion pump recall after receiving complaints of device failure and reviewing service data. Several injuries have been reported, with at least two deaths associated with the use of the hospital medication pumps.

Initially the company recommended that hospitals and medical facilities run an occluder pressure test to identify defective pumps, but the test is not effective in detecting all of the devices with misassembled occluder springs. Further inspection by the company is required, so they have now recalled all devices, which must be returned for repairs.

In a press release, Cardinal Health indicated that they are working on improvements to the design and manufacture of the infusion pumps to minimize the possibility of future defects in the assembly of the springs. Cardinal Health is a global healthcare company which is based in Dublin, Ohio. The $87 billion company ranks near the top of the Fortune 500, and is one of the largest distributers of prescription medications and medical supplies throughout the world.

HOSPITAL PUMP RECALL LAWSUITS

The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential hospital infusion pump lawsuits for any individuals who have suffered an injury due to a defective or malfunctioning infusion pump. To review a potential claim with one of our attorneys, request a free consultation.