On July 23, 2013, the FDA upgraded the June 7 recall of the MedStream Programmable Infusion Pump to a Class I recall. A Class I recall is the highest level of recall, reserved for products shown to pose the risk of serious health threats or death.
The maker of the device, Codman & Shurtleff, Inc. issued a notice on June 7 to warn the medical community of potential problems with the product.
The MedStream infusion pump was approved by the FDA in August 2012. The device is an implantable pump and catheter system that is used to deliver the drug Baclofen, which treats spasticity in individuals with cerebral palsy, stroke, spinal cord injuries or multiple sclerosis.
The recall was issued when it was determined that the Fill Level Sensor (FLS), which regulates the amount of Baclofen in the pump’s reservoir, has the potential to malfunction. There is a chance that the low reservoir alarm in the device may sound too early or too late, which could lead to an improper dosage of the medication.
In the Medical Device Corrections Notice issued by Codman & Shurtleff, physicians are urged to test the accuracy of the sensor when they see patients for refills or if patients encounter problems with their infusion pumps. Codman & Shurtleff included detailed instructions on how to test the sensors with the notice. Any physicians who encounter a malfunctioning sensor should contact Codman Neuro at 1-866-491-0974.
According to the personal injury attorneys at Berkowitz and Hanna LLC, individuals who have suffered as a result of a malfunctioning MedStream infusion pump may be entitled to financial compensation for medical bills and other damages. Such individuals are encouraged to contact the firm to learn more about their rights.