BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3880125 · Received January 30, 2014

    Report

    Report Number
    1314492-2014-05096
    Event Type
    Malfunction
    Date Received
    January 30, 2014
    Report Date
    January 3, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO.: (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE REPORTED SYMPTOM WAS CONFIRMED AND REPRODUCED. THE EVALUATION EXPERIENCED A DOOR NOT FULLY LATCHED WITH AN INSERT CLAMP ALARM CORRESPONDING WITH THE REPORTED SYSTEM OF "DOOR NOT FULLY LATCHED ALARM" CAUSED BY A LOOSE UPPER LINK SCREW. THE ALARM WAS RESOLVED DURING EVALUATION BY ADJUSTING THE SCREWS WITH THE DOOR PERFORMING AS EXPECTED. THE SCREWS WERE REPLACED DURING THE REPAIR PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DISPLAYED DOOR NOT FULLY LATCHED MESSAGE. IT WAS ALSO REPORTED THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65014 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1