Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Al

FDA device recall Z-1835-2013 · posted 2013-08-02 · Terminated

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.

Action taken

The firm, Carefusion, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 17, 2013 to all customers who purchased the Alaris PC unit (model 8015) with version 9.12-Keyboard Processor. The recall letter informs the customers of the problems identified and the actions to be taken. The customers were instructed to either discontinue use of affect PC units until remediated or continue use on patients and follow the steps provided in the letter; fully charge Alaris PC units prior to use; during operation and when not in transport, keep Alaris PC units plugged in at all times; consider having additional back up Alaris PC units available and if you experience the described error code messages on the Alaris PC unit during infusion, you may continue the infusion(s) as programmed unless a programming change is required. Obtain a back-up Alaris PC unit to replace the device. In addition, if the customer experiences a SYSTEM ERROR (111.2000 or 111.2002), or a CHANNEL DISCONNECTED error on the Alaris PC unit contact CareFusion Customer Advocacy at 888-812-3266; 24 hours a day, 7 days a week; email: customerfeedback@carefusion.com. The customers were also instructed to promptly complete and return the enclosed Customer Response Card. CareFusion will provide an update to correct the voltage on the keyboard processor for those affected Alaris PC units. Carefusion will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Customers are instructed to contact CareFusion Support Center at (888) 562-6018 or at supportcenter@carefusion.com for recall related questions; hours 7:00am to 4:00pm PT, Monday-Friday. For adverse reports, customers are instructed to contact Customer Advocacy at (888) 812-3266; 24 hours a day, 7 days a week or at customerfeedback@carefusion.com. For Technical questions, customers are instructed to call (888) 812-3229; hours 6:00pm to 5:00pm PT, Monday-Friday or at dl-us-inf-techsupport@ca

Root cause

Process design

Status

Terminated

Product code

FRN

Quantity affected

26,564 total units (26,220 units for US)

Distribution

Worldwide distribution: US (nationwide) and countries of: Australia, Canada and Europe.

Date initiated

2013-06-17

Date posted

2013-08-02

Date terminated

2014-05-20

Location

San Diego, CA

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