BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2944345 · Received January 10, 2013

    Report

    Report Number
    1314492-2013-00019
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Report Date
    December 12, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP CYCLES ON AND OFF WITHOUT USER INPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16062 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1