The U.S. Food and Drug Administration (FDA) today announced the recall of the MedStream Programmable Infusion Pump, an implanted device from Switzerland-based manufacturer Medos International SARL that is intended for the intrathecal delivery (directly to the spinal fluid) of the drug Baclofen. Baclofen is a muscle relaxer that treats muscle spasms caused by multiple sclerosis, cerebral palsy, or damage to the brain or spinal cord.
The Class I recall was initiated June 7, 2013 due to a possible malfunction in the Fill Level Sensor (FLS). The pump component is designed to measure the contents of the pump drug reservoir and the malfunction may cause the pump’s low reservoir alarm, which is normally set at 3 ml, to sound too early or too late. As a result, the recommended pump refill date may be incorrect.
The implications can be dire, as a late sounding alarm could result in a pump refill delay, which could cause medications, such as the aforementioned Baclofen, to be under delivered or discontinued. According to the recall, this could result in serious medical illness or death.
The recalled models include the 91-4200US 20 ml pump, the 91-4201US 40 ml pump, the 91-4200 20 ml pump, and the 91-4201 40 ml pump, all distributed from July 2009 through June 2013.
On June 7, 2013, the recalling firm Codman & Shurtleff, part of DePuy Synthes Companies of Johnson & Johnson, issued a Medical Device Corrections Notice that directed clinicians to evaluate the accuracy of the FLS during each patient’s next scheduled refill session — or sooner if the patient is symptomatic.
The firm provided step-by-step instructions to identify miscalibrated pumps and recommendations for patients with affected devices.
Adverse reactions or quality problems with these products can be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or via fax.
