BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3040519 · Received March 11, 2013

    Report

    Report Number
    1314492-2013-00220
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVAL AND BAXTER WAS ABLE TO CONFIRM THAT THE AUDIO FUNCTION WAS NOT PRESENT. FURTHER EVAL IDENTIFIED THAT THE ABSENCE OF AUDIO WAS DUE TO AN INADEQUATE SOLDER CONNECTION ON THE BACKFLEX. ALL DETECTION CAPABILITIES AND FUNCTIONS PERFORMED AS EXPECTED. THE FAILED BACKFLEX WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DID NOT HAVE AUDIO FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102506 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1