BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3032177 · Received March 7, 2013

    Report

    Report Number
    1314492-2013-00215
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION AND BAXTER WAS ABLE TO CONFIRM THAT THE AUDIO FUNCTION WAS NOT PRESENT. FURTHER EVALUATION IDENTIFIED THAT THE ABSENCE OF AUDIO WAS DUE TO AN UNSECURED CONNECTION ON THE INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O PCB). ALL DETECTION CAPABILITIES AND FUNCTIONS PERFORMED AS EXPECTED. THE CONNECTION WAS SECURED AND THE AUDIO FUNCTION WAS RESTORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DID NOT HAVE AUDIO FUNCTION. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98542 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1