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U.S. Department of Health and Human Services

Class 2 Device Recall Syndeo PCA Syringe Pump

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  Class 2 Device Recall Syndeo PCA Syringe Pump see related information
Date Initiated by Firm July 06, 2005
Date Posted August 16, 2005
Recall Status1 Terminated 3 on June 27, 2011
Recall Number Z-1373-05
Recall Event ID 32589
510(K)Number K031566  
Product Classification infusion pump - Product Code MEA
Product Baxter Healthcare Corporation, Medication Delivery Division, Syndeo PCA Syringe Pump, product codes 2L3113 and 2L3113R;
Code Information product codes 2L3113 and 2L3113R, all serial numbers
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		 During an infusion in the 'Basal + PCA' or 'PCA only' modes, the SYNDEO pump may generate false Service Code 919 or Service Code 920, which will cause the pump to stop the infusion. Also, while attempting to turn on the device by pressing the On/Off key, the pump may not power up properly.
FDA Determined
Cause 2		 Device Design
Action Baxter sent Important Product Information letters dated 7/6/05 to all Syndeo Pump customers, to the attention of the Director of Nursing, via first class mail. The letter informed the accounts of the scenarios they may experience regarding Service Codes 919 and 920, and the pump not being able to power up properly. Mitigation for Service Codes 919 and 920 is to turn the pump off, then turn it on again, and reprogram the infusion. If the codes occur again, the accounts were instructed to take the pump out of service and contact Baxter Medication Delivery Services at 1-800-843-7867. Any questions were referred to the Center for One Baxter at 1-800-422-9837. Baxter sent Product Withdrawal letters dated 12/11/09 to all Syndeo Pump customers, to the attention of the Director of Materials Management, with copies to the Director of Biomedical Engineering and the Director of Nursing. The letters informed the accounts that Baxter has stopped further development of the Syndeo pump platform, will pursue next generation PCA syringe pump technology and execute a controlled product withdrawal of the Syndeo pump over the next 12 months. Baxter sales representatives will contact the customers in the next few weeks to discuss options, including a Syndeo pump "buy back" plan, and to present alternative Baxter products to meet the customer's needs. The letters included a list of Syndeo pump serial numbers specific for each account, and requested the accounts to forward the letter to other facilities that they may have provided with Syndeo pumps. The accounts were requested to complete and fax back to Baxter the enclosed customer reply form, acknowledging receipt and understanding of the letter.
Quantity in Commerce 4392 units
Distribution Nationwide 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 = MEA and Original Applicant = BAXTER HEALTHCARE CORP.
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