BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3921639 · Received February 6, 2014

    Report

    Report Number
    1314492-2014-06580
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL. THE EVAL WAS ABLE TO CONFIRM THE AUDIO FUNCTION WAS NOT PRESENT. FURTHER EVAL IDENTIFIED THAT THE ABSENCE OF AUDIO WAS DUE TO A LOOSE BACK FLEX CONNECTION INTO THE J6 CONNECTOR OF THE INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O PCB). DURING THE EVAL, THE BACK FLEX WAS CONNECTED TO THE I/O PCB WITH THE DEVICE FUNCTIONING AS EXPECTED. ALL DETECTION CAPABILITIES AND VISUAL ALERT FUNCTIONS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    DURING BAXTER'S FUNCTIONAL TESTING OF A SPECTRUM DEVICE, IT WAS FOUND TO NOT HAVE AUDIO FUNCTION. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76453 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1