Recall Class: Class I
Date Recall Initiated: June 7, 2013
Products: MedStream Programmable Infusion Pump
Models: 91-4200US 20 ml pump, .91-4201US 40 ml pump, 91-4200 20 ml pump, 91-4201 40 ml pump
These affected products were distributed from July, 2009 through June, 2013.
Use: The MedStream Programmable pump is an implanted device intended for the intrathecal delivery of the drug Baclofen.
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, MA 02767
Medos International SARL
CH 2400 Le Locle, Switzerland
Reason for Recall: The Fill Level Sensor (FLS), a component of the Medstream Programmable Infusion Pump, may malfunction. The Fill Level Sensor is intended to measure the contents of the pump drug reservoir. The malfunction in the Fill Level Sensor may cause the pump’s low reservoir alarm, normally set at 3 ml, to sound too early or too late. The recommended pump refill date, computed by the Control Unit, may be incorrect. A late sounding alarm could result in a pump not being refilled in time, which could result in the under delivery or discontinuation of medications like Baclofen. This could result in serious medical illness or death.
Public Contact: For questions about this action contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to Codman Neuro at 1-866-491-0974, option 2.
FDA District: New England District Office
Physicians: No action is required beyond the recommendations provided in the Medical Device Corrections Notification letter.
On June 07, 2013, Codman issued a Medical Device Corrections Notice to consignees, via FedEx, to inform them of a potential problem with the MedStream Programmable Infusion Pump. The notice directed clinicians to evaluate the accuracy of the Fill Level Sensor, during each patient’s next scheduled refill session, or sooner if the patient is symptomatic. The firm provided a worksheet (step by step instructions) to identify pumps with a miscalibrated Fill Level Sensor and management recommendations for patients with affected devices (see link below for further details).
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.