Baxter Healthcare Corporation has recalled its Sigma Spectrum Infusion Pumps with Master Drug Library. Baxter received over 3500 reports of System Error 322 “Link Switch Error (low)” incidents in which the device has malfunctioned, including nine severe adverse events and no deaths. The System Error 322 occurs when the pump improperly detects that the door is open when it is physically closed. A System Error 322 may lead to an interruption or delay in therapy.
If the System Error 322 occurs, the Sigma Spectrum infusion pump stops the infusion, an alarm sounds, and a light flashes (a visual “322” alarm). This requires a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.
Sigma Spectrum Infusion Pumps with Master Drug Library are intended to deliver controlled amounts of intravenous fluids including medicines, blood, blood products and other mixtures required by patients. The routes of administration include a vein or an artery, under the skin, into the spine, and other acceptable routes. The Sigma Spectrum Infusion Pumps with Master Drug Library are used in, but not limited to, hospitals, outpatient care, and home care.
The Sigma Spectrum Infusion Pumps with Master Drug Library affected by the recall are Model No. 35700BAX and 35700ABB. The affected products were manufactured by Baxter Healthcare Corporation of Deerfield, IL from July 1, 2005 through January 15, 2014 and distributed from February 20, 2013 through January 15, 2014.
The use of affected product may cause serious adverse health consequences, including 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.
See the Recall
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication