Company: CareFusion 303, Inc.
Date of Enforcement Report 8/1/12
Date Recall Initiated: May 25, 2012
Class l:
PRODUCT
Alaris PC unit, model 8015 with PC unit power supply board P/N TC10005122, manufactured after January 2011. Affected product was distributed from January 1, 2011, to May 31, 2012.
The Alaris PC unit, model 8015 is part of the Alaris electronic infusion pump. Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.
REASON
A component on the PC unit power supply board is causing an error code (120.4630): “System Error” or “Missing Battery Error” to occur. The error code is accompanied by both an audible alarm and a visual error message on the PC unit screen. If the error code occurs at start-up, the Alaris infusion pump cannot be programmed and this may cause a delay in patient therapy. If the error code occurs during infusion, the health care provider cannot make programming changes to current infusions, and this may result in serious injury and/or death to the patient.
RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc.,San Diego, California
FDA District:Los Angeles
FDA Comments:
On June 27, 2012, CareFusion sent an Urgent Medical Device Recall Notice2 to customers who purchased the Alaris PC unit, model 8015. The following recommendations were included in that letter:
Do not return the affected devices.
If the error messages noted above are observed, remove the PC unit from use and contact the CareFusion Recall Support Center at 1-888-562-6018.
For clinical areas administering high-risk infusions, consider having additional devices as back-up until affected devices are remediated.
Complete and return the customer response card enclosed with the letter to expedite the corrective action process.
CareFusion will contact customers by phone within 60 days of receiving the letter to schedule a visit to replace the affected power supply board on the PC unit..
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