BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3003612 · Received February 11, 2013

    Report

    Report Number
    1314492-2013-00084
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION. THE EVAL CONFIRMED A "CHECK BATTERY" ALARM AND FOUND THAT WHILE OPERATING ON POWER SUPPLIED FROM A BATTERY MODULE ONLY, THE DEVICE IS ABLE TO POWER ON WITHOUT USER INPUT, ENTER SLEEP MODE AND SHUTDOWN WITHOUT USER INPUT. THE CAUSE WAS DETERMINED TO BE CONTACT BETWEEN THE SCANNER BRACKET SCREW AND THE 2 TRACES OF THE BACKFLEX CAUSING SHORTING. THE SUBMISSION COMPLAINT IS DUE TO THE RISK ASSOCIATED WITH AN INTERMITTENT POWER UP, ENTER SLEEP MODE AND POWER DOWN WITHOUT USER INPUT. AT THIS TIME, THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED TO "CHECK BATTERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59544 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1