—#109684

Product

Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K051641
Affected lot / code info: not available

Why it was recalled

The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen.

Root cause (FDA determination)

Component design/selection

Action the firm took

Carefusion sent an Urgent: Medical Device Recall Notification letter dated June 27, 2012 to all their customers who purchased the Alaris PC unit (model 8015). The letter identified the affected units, explanation of the problem, potential risk and actions to be taken. Customers were instructed to not return their devices. If customers observe either of the error messages identified in the letter, then they were instructed to remove the PC unit from use and contact the Carefusion Support Center. Carefusion will contact their facility by phone within 60 days of receiving this notification to schedule a visit to replace their affected power supply board on their PC unit. Customers were instructed to promptly complete and return the enclosed customer response card to expedite the corrective action process. For questions and support contact: CareFusion Support Center at 888-562-6018 for (Recall Related Questions), Customer Advocacy at 800-854-7128, Option 1, Option 1, Option 3 or email customerfeedback@carefusion.com for (Adverse Event Reports), Technical Support at 888-812-3229 for (Technical Questions Regarding the Alaris System).

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2012-05-25
Posted by FDA: 2012-07-26
Terminated: 2014-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109684. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.