BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3032136 · Received March 6, 2013

    Report

    Report Number
    1314492-2013-00204
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL AND THEREFORE AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DURING THE COMPLAINT EVAL, THE CUSTOMER STATED THAT THE INADVERTENT BOLUS WAS DUE TO HUMAN ERROR AND NO MALFUNCTION OF THE PUMP OR IV SET WAS OBSERVED. MFR REPORT NO. 1314492-2013-00203 IS RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE IV SET WAS REMOVED FROM A SPECTRUM PUMP, THE PT REC'D AN INADVERTENT BOLUS OF MAGNESIUM. THE CUSTOMER STATED THAT THE NURSES ASSUMED THAT WHEN THE IV SET WAS REMOVED FROM THE PUMP, THE TUBING WOULD CLAMP ON ITS OWN. IT WAS ALSO REPORTED THAT THIS OCCURRED TWO TIMES WITH PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96515 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1