Credit: Daniel Gay
Hospira, Inc., has issued a Class I recall of Abbott Acclaim infusion pumps and Hospira Acclaim Encore infusion pumps, after receiving reports of broken door assemblies on these products.
If a door assembly breaks, the door may not close properly and an over-infusion or a delay of therapy may occur.
If the door cannot be closed, the pump cannot be used, and this can result in a delay of therapy.
Use of these products may cause serious adverse events, including death.
These pumps are used to deliver hydration fluids, drugs, blood and blood fractions, intravenous nutritionals, and enteral nutritionals.
The affected Abbott Acclaim Infusion Pumps, list Number 12032, were manufactured from February 1998 to November 1998 and distributed from September 1998 through February 2004.
The affected Hospira Acclaim Encore infusion pumps, list Number 12237, were manufactured from February 1997 to February 2010 and distributed from July 1999 through November 2013.
Hospira is recommending that users inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks prior to programming a therapy, by taking the following steps:
1. After inserting the tubing (with the roller clamp closed) and closing the door handle against the infusion pump, check that the door is fully closed.
If a pump has a door that does not close properly and a gap or separation exists between the completely closed door and the pump itself, remove the pump from clinical service, and call Hospira at 1-800-441-4100 (M-F, 8am-5pm, CT). If the door closes correctly, proceed to Step 2.
2. If the door closes correctly and a gap or separation does not exist between the completely closed door and the pump itself, check that there is no free flow activity in the drip chamber of the administration set by opening the roller clamp.
If free flow is detected, close the roller clamp, remove the pump from clinical service, and call Hospira at 1-800-441-4100 (M-F, 8am-5pm, CT).
3. If no issues are found through steps 1 and 2, the pump is acceptable for use. However, healthcare professionals should still ensure that anyone in their facility who might use these products is made aware of this safety notification and the recommended actions.
Healthcare professionals and patients can report adverse events or side effects related to the use of these products to the FDA’s MedWatch Program.
