CareFusion just issued a recall for another infusion pump, the U.S. Food & Drug Administration (FDA) just announced.
The FDA notified healthcare professionals that this recall involves CareFusion 303, Alaris Pump Module, Model 8100. This device was formerly known as the Medley Pump Module. According to Reuters, the recall was implemented over a potential keypad malfunction in the infusion pump that could lead to serious injury or death. The serious nature of the defect led to a Class I recall designation, the agency’s most serious. The defective infusion pump was manufactured between October 2011 and February 2012, said Reuters. The door assembly with keypad part number is TC10005926.
The keypad malfunction involves the potential for the pump module door keypad overlay to become loose, peel away, or separate from the door assembly, which could lead to potential for fluid ingress. This could lead to a keypad malfunction, causing the infusion to stop with alarm. When infusion stops, serious injury or death may result.
The pump module is intended for healthcare facilities that use infusion for the delivery of fluids, drugs, blood, and blood products using continuous or intermittent delivery through intravenous, intra-arterial, subcutaneous, epidural, enteral, or irrigation of fluid spaces routes of administration. The pump module is used for adults, children, and newborns.
Reuters noted that, earlier this month, the FDA also announced another Class I recall involving the CareFusion Alaris PC unit Model 8015 over a malfunction in its power supply board.
We recently wrote that the CareFusion EnVe Ventilator recall was deemed a Class I and updated CareFusion’s previously announced recall of its EnVe ventilators. We also reported that the FDA deemed the CareFusion AirLife Infant Breathing Circuit a Class I recall and earlier this year, we wrote that CareFusion NicoletOne Software and Nicolet devices were named in a Class I recall. Prior to that, we wrote that, in three separate actions, CareFusion updated its AVEA® ventilator recall; that certain CareFusion EnVe Ventilators were recalled; and that CareFusion issued a recall for some of its Alaris PC Units electronic infusion devices. The FDA deemed all three actions Class I recalls.
Beginning July 20, 2012, CareFusion sent affected customers and distributors an URGENT: Medical Device Recall Notification letter, FAQs, Summary of Affected Units and Response Card by overnight courier service delivered upon signed receipt. The Recall Notification letter identified the problem and required action. Customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation and CareFusion informed customers that they will contact their facility, by telephone, within 60 days of receiving the letter to schedule a visit to replace the door assembly on the affected pump module.
Customers with recall-related questions were instructed to contact CareFusion Support Center, toll-free, at 1.888.562.6018. Customers with questions about adverse event reports were instructed to contact Customer Advocacy at 1.800.854.7128, option 1, option 1, option 3, or by email at email@example.com. Customers with technical questions were instructed to contact technical support at 1.888.812-3229, 7:00 a.m. to 5:00 p.m., Pacific Time (PT).
A complete list of serial numbers, the customer letter, and FAQ can be accessed on Care Fusion’s web site at: http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-alaris-pump-module-8100-keypad-overlay.aspx.