A recall has been
issued for the Baxter Healthcare Corporation Sigma Spectrum Infusion Pumps
with Master Drug Library Model No. 35700BAX and 35700ABB. Baxter has
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. For
more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm395617.htm
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