Alaris (Medley) Infusion Pumps Recalled

Posted on April 29, 2008

Cardinal Health is recalling all Alaris Infusion Pump modules shipped before September 27, 2007. The products, which are Model 8100, were formerly known as Medley Pump modules.

The company recalled these units after receiving reports of inaccurate flow rates. The problem is that the occluder springs, which control medication flow, may have been misassembled during manufacturing or servicing. Misassembled springs can lead to overinfusion, which could result in serious health consequences or death.

The company says that overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there's no warning or notification when an overinfusion does occur.

Cardinal Health plans to inspect all of the recalled units and repair those with misassembled springs. Until this process is completed, the company is recommending that facilities perform an occluder pressure test on their Alaris pump modules using the method outlined in updated Service Bulletin 528A. A unit that fails this test should be taken out of service. However, since the test may not be able to detect all misassembled springs, the company will still need to inspect all of the recalled units.

For more information, contact the Alaris Pump Module Call Center at 800-625-6627.

Additional Information:

FDA MedWatch Safety Alert. Cardinal Health Alaris Pump Module. December 26, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#cardinal

Cardinal Health. Alaris Pump Voluntary Recall Update. December 27, 2008.
http://www.cardinalhealth.com/alaris/brochure/Alaris%20Pump%20Recall%20Classification%20Letter.pdf

Cardinal Health. Updated service bulletin 528A at
http://www.cardinalhealth.com/alaris/brochure/PumpModuleRecallServiceBulletin.pdf