—#40398

Product

Baxter Healthcare Corporation, Medication Delivery Division, Syndeo PCA Syringe Pump, product codes 2L3113 and 2L3113R;

FDA product code: MEA — Pump, Infusion, Pca
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K031566
Affected lot / code info: product codes 2L3113 and 2L3113R, all serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2005-07-06
Posted by FDA: 2005-08-16
Terminated: 2011-06-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40398. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.