BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2760210 · Received September 20, 2012

    Report

    Report Number
    1314492-2012-00292
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Report Date
    August 22, 2012
    Manufacturer
    BAXTER HLTHCARE CORPORATION
    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). SIGMA EVALUATED THE DEVICE IN QUESTION. THE EVAL CONFIRMED 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. FURTHER EVAL FOUND THAT THIS WAS CAUSED BY A SHORTED BACK FLEX.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE POWERED ON, A PUMP WILL POWER OFF THEN POWER BACK ON WITHOUT USER INPUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1