—#38881

Product

Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K945942
Affected lot / code info: serial numbers 12040401AB through 12040420AB, serial number 12050501AB and above, and those pumps that had syringe clamp assembly AAS5001503RP replaced on refurbished or serviced AS50 pumps since 5/14/02.

Why it was recalled

A 'Check Flange' alarm may occur even though the syringe has been properly loaded into the AS50 Infusion Pump. The false alarm may occur during the syringe loading process or while an infusion is running. Also, the occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.

Root cause (FDA determination)

Other

Action the firm took

Urgent Device Correction letters dated 5/5/05 were sent to the AS50 customers via first class mail to the attention of the Director of Nursing. The accounts were informed of the false 'Check Flange' alarms due to a combination of certain syringe clamp assemblies on a specific serial numner range of pumps and the dimensional attributes of the Monoject 35 cc syringes. The accounts were requested to check the serial numbers on their AS50 pumps against the listing of serial numbers in the letter and contact Baxter Medication Delivery Services at 1-800-843-7867 for information regarding the return process to screen and replace the syringe clamp assemblies. The accounts were also informed of the delay in the detection of a downstream occlusion when the AS50 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. The accounts were requested to complete and fax back the enclosed reply form indicating that they have examined their inventory for AS50 pumps, and listed the affected serial numbers found to be returned to Baxter for correction. Baxter extended the recall on 1/24/06 to 43 customers who received the pumps after the "check Flange Alarm" issue had been corrected in production, but had not been notified of the "Delay in Detection of Downstream Occlusion" issue. Copies of the Operator's Manual Addendum addressing the delay issue were included with the letter. Baxter also sent copies of the Operator's Manual Addendum to all of the accounts who received the 5/5/05 le

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Nationwide including Puerto Rico, and internationally to Colombia, Chile, Brazil, Saudi Arabia and Canada.

Timeline

Recall initiated: 2005-05-06
Posted by FDA: 2005-11-18
Terminated: 2008-06-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38881. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.