[Posted 05/02/2014]

AUDIENCE: Risk Manager, Biomedical Engineer, Nursing

ISSUE: Hospira received customer reports of broken door assemblies on the Abbott Acclaim infusion pumps and the Hospira Acclaim Encore infusion pumps. When the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to the patient. If the door assembly breaks, it may prevent the door from closing properly and an over-infusion or a delay of therapy may occur. If the door cannot be closed, the pump cannot be used which can result in a delay of therapy.

Use of these affected products may cause serious adverse health consequences, including death.

BACKGROUND: Affected Abbott Acclaim Infusion Pumps, list Number 12032 were manufactured from February 1998 to November 1998 and distributed from September 1998 through February 2004. 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.

RECOMMENDATION: Hospira recommends that users inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks, prior to programming a therapy, by following the steps outlined below:

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.
• For pumps where the door closes correctly, proceed to Step 2.

2. For pumps with the door closing 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.

3. If no issues are found through steps 1 and 2, the pump is deemed acceptable for use. Additionally, please take the following actions related to this safety notification:

1. Ensure that all potential users in your facility are made aware of this safety notification and the recommended actions.
2. Complete the reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. Contact Stericycle at 1-866-891-0586 (M-F, 8am-5pm, ET) to obtain additional copies of the reply form, if needed.
3. If you have further distributed the Hospira/Abbott Acclaim Encore infusion pumps, please notify your customers who may have received these infusion pumps from you and ask them to contact Stericycle at 1-866-891-0586 (M-F, 8am-5pm, ET) to receive a reply form.

Product Correction:

After following the instructions above, if you determine that a pump has a door that does not close correctly or if free flow is detected while the administration set is in the pump with the door closed, close the roller clamp, remove the pump from clinical service and call Hospira.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/02/2014 - Recall Notice - FDA]