The FDA is warning that Acclaim infusion pumps sold by Abbott and Hospira may place patients at a risk of serious injury or death, due to broken doors that may delay the delivery of medication or cause drug overdose.
Last week, the FDA determined that an Acclaim Infusion Pump recall should be classified as a class 1 medical device recall. The classification means the agency believes that the problems with the pump could lead to serious injury or death. However, neither the FDA nor Hospira are aware of any actual injuries or deaths that may be associated with the problem.
The infusion pumps are used to deliver medications, blood or blood products and other medical fluids into a patient’s body. The original recall was issued on October 31, 2013, following customer reports of broken door assemblies. If the door is not closing properly, it could lead to over-infusion or a delay in treatment. Either of these problems could result in fatal injuries for some patients.
The recall affects Abbott Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps with list numbers 12032 and 12237. The affected Abbott pumps were manufactured from February 1998 to November 1998 and distributed from September 1998 through February 2004. Affected Hospira infusion pumps were manufactured from February 1997 through February 2010 and distributed from July 1999 through November 2013.
Hospira provided customers with instructions on how to check the infusion pump for cracks before programming therapy. The company also called on customers to make sure that health care professionals that might use the device be aware of the problem. Those who find their devices are damaged should stop using them immediately and call Hospira at (800) 441-4100.