Sensor Malfunction Leads to MedStream Infusion Pump Recall
A malfunctioning sensor in Medstream Programmable Infusion Pumps could cause serious illness or death, the FDA warns.
The FDA announced on July 23 that it has determined that a MedStream Programmable Infusion Pump Recall should be considered Class I, which is the most serious recall category for a medical device.
The decision follows a Medical Device Corrections Notice (PDF) sent out by Codman & Shurtleff, Inc. on June 7, warning customers of a potential problem with the infusion pump.
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The MedStream infusion pump is designed to deliver the drug Baclofen, which treats spasticity caused by cerebral palsy, multiple sclerosis and other diseases and conditions. However, the FDA warns that the Fill Level Sensor (FLS) may malfunction.
The FLS measures the amount of medication in the pump drug reservoir. This could cause the low reservoir alarm to sound too early or too late. This could lead to the pump not being refilled in time and patients not getting the proper dosage.
The recall affects the MedStream Programmable Infusion Pump models 91-4200US 20 ml pump, .91-4201US 40 ml pump, 91-4200 20 ml pump, and 91-4201 40 ml pump. They were manufactured by Medos International SARL of Switzerland and distributed from July 2009 through June 2013.
The notice sent out by Codman & Shurtleff told physicians to evaluate the accuracy of the FLS during their patient’s next scheduled refill or if the patient appears to be having problems. A worksheet was provided in the notice that gave doctors step-by-step instructions on how to identify a malfunctioning sensor. If a malfunctioning sensor is found, they should report it to Codman Neuro at 1-866-491-0974, option 2.
Customers with questions can contact Codman Neuro Clinical Support at 1-800-660-2660
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