Device Recall Baxter Auto Syringe AS40 and AS40A Infusion Pumps 의 리콜

Recall

34579

Class 2

Z-0599-06

2006-02-08

2006-03-07

Terminated

United States

2010-01-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44130

The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.

Important Product Information letters dated 2/8/06 were sent to the AS40 customers via first class mail to the attention of the Director of Nursing. The accounts were informed of the delay in the detection of a downstream occlusion when the AS40 pump is used with large volume syringes at low flow rates. To minimize the occlusion detection times at low flow rates, Baxter recommended that the customers take the following actions: * Use the smallest possible syringe size for the volume of fluid to be delivered; * Select the low occlusion pressure setting to minimize the detection time; * Utilize infusion sets with thick-walled, small bore tubing to minimize the detection time; and * Always verify that the clamping device or stopcock is open in the fluid path prior to starting an infusion.