Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infu

FDA device recall Z-2185-2012 · posted 2012-08-15 · Terminated

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011.

Action taken

CareFusion sent an Urgent Medical Device Recall Notification letter dated July 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Required action for users instructed high risk patients undergoing infusions at high rates, consider having additional devices as back up. Clinicians should weigh the risk/benefit to the patients before continuing to use the device. Customers with recall related questions were instructed to contact Carefusion support center at (888) 562-6018. Customers with adverse event report questions were instructed to contact customer advocacy at (800) 854-7128, option 1, option 1, option 3 or email at customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris system were instructed to contact Technical support at (888) 812-3229. For questions regarding this recall call 858-617-4000.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FRN

Quantity affected

102,248 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of: South Africa and Canada. Additional Countries: Netherlands.

Date initiated

2012-06-29

Date posted

2012-08-15

Date terminated

2015-08-26

Location

San Diego, CA

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