Device Recall Baxter 6060 & Sabratek 6060 Homerun MultiTherapy Infusion Pump 의 리콜

Recall

33999

Class 2

Z-0411-06

2005-11-07

2006-01-28

Terminated

United States

2007-06-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42885

Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the power-on self test.

Baxter sent Urgent Device Correction letters dated 11/7/05 to the user accounts, advising them of the potential for the circuit boards in the 6060 pump to fail due to a problem that occurred in the supplier's manufacturing process. The letter included a list of 6060 pump serial numbers sent to the user that may contain an affected circuit board. To mitigate safety risks to the patient, Baxter advised customers to immediately discontinue use of the pump for therapies where interruption of the infusion could cause immediate patient harm. In addition, the pump is not to be used if it fails the Power-On Self Test. The accounts were instructed to contact Baxter Medication Delivery Services at 1-800-843-7867 for information regarding the return process for the affected 6060 pumps for correction. Baxter sent follow-up letters dated 2/16/06 to the accounts, to the attention of the Director of Biomedical Engineering, informing them that Baxter has sufficient quantities of replacement circuit boards to begin the repairs. The accounts were requested to review the enclosed list of serial numbers for accuracy and telephone Baxter at 1-800-843-7867 to schedule the return of any 6060 Infusion Pump that requires replacement of the circuit board.