BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED 350 VL AMBULATORY PUMP

    MDR report key: 8417942 · Received March 13, 2019

    Report

    Report Number
    8417942
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    January 22, 2019
    Report Date
    January 30, 2019
    Manufacturer
    WALKMED LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT INTO LCI TODAY FOR CIV PUMP CHEMO CASSETTE CHANGE. CHEMO CASSETTE IS SET TO INFUSE OVER 24 HOURS. WHEN PATIENT ARRIVED FOR CASSETTE CHANGE SHE STILL HAD APPROXIMATELY 240CC (OF 500CC) LEFT TO INFUSE EVEN THOUGH IT SHOULD HAVE BEEN COMPLETED. UPON INSPECTION THE TUBING IN THE PUMP WAS TWISTED AND WEDGED UNDER THE PLASTIC COVER CREATING A PARTIAL OCCLUSION. PATIENT REPORTS THE PUMP DID NOT ALARM OCCLUSION DURING THE NIGHT. THIS RN DID CLAMP THE TUBING TO CHECK THE OCCLUSION ALARM AND IT DID ALARM AS EXPECTED. HER LEFT PICC WAS FLUSHED AND HAD AN EXCELLENT BLOOD RETURN. DOCTOR WAS NOTIFIED. THE REMAINDER OF UN-INFUSED CHEMO WAS WASTED AND A NEW BAG WAS INITIATED PER DOCTOR'S ORDER. THE NEW TUBING WAS TAPED IN THE PUMP SO IT COULD NOT MOVE WITHIN THE CHAMBER. THE PUMP WAS TURNED ON AND OBSERVED INFUSING WITHOUT ALARM FOR 30 MINUTES. THE TUBING WAS ALSO CLAMPED TO TEST THE ALARM AND IT DID ALARM OCCLUSION AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208602 WALKMED 350 VL AMBULATORY PUMP PUMP, INFUSION FRN WALKMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA