MedStream Programmable Infusion Pump and Refill Kits were recalled because air in the pump reservoir may release a higher dosage of drug than expected, leading to drug overdose. The MedStream Programmable Infusion Pump is an implanted drug delivery system used in the U.S. for the chronic delivery of Baclofen, a muscle relaxer derived from gamma-aminobutyric acid (GAMA) to treat muscle spasms caused by multiple sclerosis, cerebral palsy, or damage to the brain or spinal cord. In Europe, the Middle East, and Africa the pump is used for the chronic delivery of Morphine or Baclofen. Refill kits are used in filling and re-filling the MedStream pump reservoir.
This product may cause serious adverse health consequences, including low blood pressure (hypotension), an abnormally slow heart rate (bradycardia), loss of consciousness, and/or death. The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
The 20mL and 40mL pumps are involved along with the refill kits. The affected products were manufactured from March 2009 to September 2012 and distributed from January 8, 2010, to July 19, 2013.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication