BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3062598 · Received March 18, 2013

    Report

    Report Number
    1314492-2013-00258
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 A FAILED ONE WATT SPEAKER. THE FAILED SPEAKER WILL BE REPLACED. ALL DETECTION CAPABILITIES AND FUNCTIONS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAS NO AUDIO FUNCTION. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111633 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1