BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2953978 · Received January 15, 2013

    Report

    Report Number
    1314492-2013-00027
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION. THE EVALUATION 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. THE CAUSE WAS DETERMINED TO BE CONTACT BETWEEN THE SCANNER BRACKET SCREW AND THE 2 TRACES OF THE BACKFLEX CAUSING SHORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "PUMP WILL AUTOMATICALLY TURN ITSELF ON AFTER THE DEVICE IS POWERED OFF." IT WAS ALSO REOPERATED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22165 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1