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News & Press: Rx Alerts

Medical Device Safety and Recalls: Baxter Healthcare Corporation, Sigma Spectrum Infusion Pumps with

Wednesday, May 7, 2014   (0 Comments)
Posted by: Shannon Glaittli
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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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