Device Recall Baxter PCA II Syringe Infusion Pump 의 리콜

Recall

34244

Class 2

Z-0553-06

2005-12-21

2006-04-26

Terminated

United States

2008-11-03

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43327

Delivery of unrequested pca doses of medication due to damaged pca cords, partial sticking of pca button, and fluid ingress into the pump or pca button.

Baxter sent Urgent Device Correction letters dated 12/21/05 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for unrequested PCA doses due to an electrical short in the PCA circuit simulating repeated pressing of the PCA button. The unrequested bolus doses will not exceed the programmed prescription limits. The letter listed three conditions identified that can produce an electrical short in the PCA circuit and simulate repeated pressing of the PCA button: * Damaged PCA cord or button, * Partial sticking of the PCA button, and * Fluid ingress into the pump or PCA button. Information was provided to reduce the potential for these conditions from occurring during use of the pumps. Customers were asked to ensure that prior to or after each use the PCA cord is intact and has no cuts or missing insulation, and that the pump connector and the button are securely attached to the cord. They were also asked to immediately take the pump and PCA cord out of service for repair if the pump displays 'Release the PCA Button' and the PCA button is not being intentionally pressed, as there may be a mechanical or electronic fault in the PCA button. They were also asked two avoid getting liquids inside the pump as permanent damage may result. Baxter recommended that the institutions implement a regular preventative maintenance program and periodic replacement of the PCA cords based on their own specific usage patterns. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter sent a follow-up recall letter to the accounts on 6/21/06, providing them with an Operator's Manual Addendum for the AP II Infusion Pump and the PCA II Infusion Pump, with the warnings to ensure that prior to or after each use that the PCA cord is intact and has no cuts or missing insulation, and that the pump connector and the button are securely attached to the cord; to avoid getting liquids inside the pump; and