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Plum A+ and Plum A+3 Infusion Systems by Hospira: Class I Recall - Alarm Volume Failure
AUDIENCE: Risk Manager, Oncology
ISSUE: The Plum A+ and A+3 infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound in situations that should trigger it. It is possible for a long delay before a health care professional becomes aware of the need to restore therapy. For patients receiving critical intravenous medication, there is a risk of injury or death resulting from this prolonged interruption in therapy. See the Recall Notice for a listing of products affected by this recall.
BACKGROUND: Manufacturing and distribution dates: July 2012 to May 2014. Date recall initiated: May 28, 2014
RECOMMENDATION: Stericycle, Inc. sent two Urgent Medical Device Correction letters dated July 2, 2014 and July 16, 2014 to customers. The letters notified customers that Hospira would contact them regarding the completion of an audible alarm test and will replace any alarm assemblies that fail to audible alarm test. Hospira has contracted with Stericycle, Inc., in Indianapolis, IN for customer notification, response tracking, returns, effectiveness checks and destruction of product returns. Questions should be directed to Stericycle at 888-912-7350 (Monday - Friday, 8:00 AM - 5:00 PM ET).
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
- 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
Read the MedWatch safety alert, including a link to the recall notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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