Medstream Infusion Pump Recall Issued Due to Overdose Risk
According to a warning issued by federal health regulators, recalled MedStream Infusion Pump and Refill Kits may cause a drug overdose in patients that could pose a risk of serious injury or death.
Massachusetts based company Codman & Shurtleff initially issued a MedStream Infusion Pump recall on August 13, 2013, after the manufacturer discovered a problem that may allow air to enter the pump reservoir.
This week, the FDA announced that this action constituted a class 1 medical device recall, which is the most serious type of recall, reserved for situations where continued use of the product carries a high probability of severe health consequences, including death.
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Air in the reservoir of the recalled infusion pumps may release higher dosages of the drug than expected, causing drug overdose, the company and FDA warn. The problem may also result in other serious side effects, including low blood pressure, abnormally slow heart rate, loss of consciousness and death.
The MedStream Programmable Infusion Pump, which is manufactured in Switzerland, is an implanted drug delivery system that is used in the United States for chronic delivery of Baclofen, a muscle relaxant used to treat muscle spasms caused by multiple sclerosis, cerebral palsy or damage to the brain or spinal cord.
The MedStream Infusion Pump is also used in Europe, the Middle East and Africa for the chronic delivery of Morphine and Baclofen. Making the risk of drug overdose much more serious in other countries.
The recall affects pumps and refill kits which were manufactured March 9 through September 12 and distributed January 8, 2010 to July 19, 2013. The refill kit is used to refill the MedStream pump reservoir.
Codman & Shurtleff issued a Medical Device Field Safety Notice letter on August 13, notifying customers of the recall and updated product training materials. The update added a warning statement about potential overdose if air is caught inside the pump reservoir. Clarification to reinforce the proper filling technique of the pump reservoir with the refill kit were also included in the letter.
Customers are asked to complete a Field Safety notice Acknowledgment Form and return it to Codman & Shurtleff. They are also asked to report any adverse events concerning the MedStream Programmable Infusion Pumps and refill kits to Codman and Shurtleff directly.
MedStream Programmable Pump and refill kit product codes affected by the recall include: US: 91 -4200 EMEA: 91 – 4200; US: 91 -4201 EMEA: 91 – 4201; US: 91 -4287 EMEA: 91 – 4289; US: 91 -4288 EMEA: 91 – 4290.
Customers with questions can call Dodman Neuro Clinical Support at (800) 660-2660.
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