A Class 1 recall has been issued for the MedStream Infusion Pump, which is an implantable medical device used to deliver constant doses of Morphine or Baclofen. The problem is that air in the pump reservoir could release a higher dose of drugs than expected, which could cause a drug overdose. Complications could include low blood pressure, slow heart rate, loss of consciousness, and death.
What is the MedStream Infusion Pump?
The MedStream Programmable Infusion Pump is an implanted medical device that is manufactured by Codman & Shurtleff, Inc. It delivers constant doses of the following drugs:
- Morphine: A narcotic pain-reliever that is used to treat moderate to severe pain.
- Baclofen: A muscle-relaxing and anti-spastic drug that is used to treat muscle symptoms caused by multiple sclerosis, including spasms, pain, and stiffness.
What is the problem?
Air in the pump reservoir may release a higher dosage of drug than expected, leading to a drug overdose. The FDA and Codman & Scurtleff, Inc. issued a Class 1 recall for the MedStream Programmable Infusion Pump and the MedStream Refill Kit on October 23, 2013. This is the most serious type of recall, reserved for devices that could potentially cause life-threatening injuries or death.
What MedStream Infusion Pumps were Recalled?
| Products | Product Codes |
|---|---|
| MedStream Programmable Pump; 20 mL | US: 91 – 4200EMEA: 91 – 4200 |
| MedStream Programmable Pump; 40 mL | US: 91 – 4201EMEA: 91 – 4201 |
| MedStream Refill Kit | US: 91 – 4287EMEA: 91 – 4289 |
| MedStream Refill Kit; 6 Pack | US: 91 – 4288EMEA: 91 – 4290 |
The products were manufactured between March 2009 and September 2012. They were distributed from January 2010 until July 2013.
Side Effects of the MedStream Infusion Pump
- Drug overdose
- Low blood pressure (hypotension)
- Slow heart rate (bradycardia)
- Loss of consciousness
- Death
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