July 17, 2013
A malfunction has been detected in the Fill Level Sensor (FLS) component of the Medstream Programmable Infusion Pump that may cause the pump’s low reservoir alarm, normally set at 3 ml, to sound too early or too late.
The affected products were distributed from July, 2009, through June, 2013, and include Models 91-4200US 20 ml pump, .91-4201US 40 ml pump, 91-4200 20 ml pump and 91-4201 40 ml pump.
Clinicians have been directed to evaluate the accuracy of the Fill Level Sensor during each patient’s next scheduled refill session or sooner if the patient is symptomatic. Click here for additional recommendations.
Based upon reported complaints, approximately 1% of implanted MedStream pumps may have been affected by this issue. There have not been any reports of corresponding deaths or permanent patient injuries.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online
Download form or call 1.800.332.1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1.800.FDA.0178
Read the MedWatch Safety Alert, which includes a link to the Recall Notice.