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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter IPump Pain Management System Infusion Pump

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 Class 2 Device Recall Baxter IPump Pain Management System Infusion Pumpsee related information
Date Initiated by FirmFebruary 10, 2005
Date PostedNovember 16, 2005
Recall Status1 Terminated 3 on November 03, 2008
Recall NumberZ-0130-06
Recall Event ID 31191
510(K)NumberK993387 
Product Classification Pump, Infusion - Product Code FRN
ProductBaxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015
Code Information product codes 2L3107 and 2L3107R, all serial numbers
FEI Number 1416980
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump.
FDA Determined
Cause 2		Other
ActionBaxter mailed Urgent Device Correction letters dated 2/10/05 to the domestic accounts on 2/10/05 via first class mail, to the attention of the Director of Nursing, advising them of the following hardware problems and software anomalies and providing workarounds for each. There are potential failures of the pump due to upstream occlusion alarms, electro-static discharge, Key-Only security mode (previously covered by letter dated 4/10/02), system error 32 or 33 codes, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump. The accounts were advised that as soon as revised software and hardware is available, Baxter would modify the pumps at no additional charge to the consignee. Any questions were directed to their Baxter Medication Delivery Product Information Center at 1-800-933-0303.
Quantity in Commerce24,009 pumps
DistributionNationwide including Puerto Rico, and internationally through Baxter subsidiaries in Canada, Chile, Hong Kong, Kuwait and Saudi Arabia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
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