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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Auto Syringe AS50 Infusion Pump

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  Class 2 Device Recall Baxter Auto Syringe AS50 Infusion Pump see related information
Date Initiated by Firm May 06, 2005
Date Posted November 18, 2005
Recall Status1 Terminated 3 on June 23, 2008
Recall Number Z-0159-06
Recall Event ID 31992
510(K)Number K945942  
Product Classification Pump, Infusion - Product Code FRN
Product Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.
Code Information 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.
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
Action 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
Quantity in Commerce 10,414 pumps
Distribution Nationwide including Puerto Rico, and internationally to Colombia, Chile, Brazil, Saudi Arabia and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORP.
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