BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2881219 · Received November 14, 2012

    Report

    Report Number
    1314492-2012-00415
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION AND THE PUMP-SIDE POLE CLAMP ADAPTOR WAS OBSERVED TO BE DAMAGED. FURTHER EVALUATION FOUND THAT THE PUMP'S AUDIO FUNCTION WAS NOT PRESENT. THE ABSENCE OF AUDIO WAS DUE TO A FAILED 1 WATT SPEAKER. ALL DETECTION CAPABILITIES AND FUNCTIONS PERFORMED AS EXPECTED. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR PATIENT INJURY THAT COULD RESULT FROM THE LACK OF AUDIO FUNCTION. AT THIS TIME, THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAD A BROKEN PUMP-SIDE PLE CLAMP ADAPTOR. DURING THE EVALUATION, IT WAS ALSO FOUND THAT THE PUMP HAD NO AUDIO FUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1