BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2983203 · Received January 31, 2013

    Report

    Report Number
    1314492-2013-00061
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION. IT WAS CONFIRMED THAT THE AUDIO FUNCTION WAS NOT PRESENT. FURTHER EVALUATION IDENTIFIED THAT THE ABSENCE OF AUDIO WAS DUE TO A FAILED 1 WATT SPEAKER. ALL DETECTION CAPABILITIES AND FUNCTIONS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING, A PUMP WOULD ALARM FOR AN UPSTREAM OCCLUSION, HOWEVER, THE 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
    43713 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1