BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED®

    MDR report key: 6910225 · Received October 3, 2017

    Report

    Report Number
    6910225
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 19, 2017
    Manufacturer
    WALKMED INFUSION LLC
    Product Code
    BTC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT DID NOT ACTUALLY RECEIVE MEDICATION DUE TO ADVERSE DRUG EVENT FROM ANOTHER MEDICATION. THIS PATIENT'S FLUOROURACIL (5-FU) BAG WAS MADE AND STORED FOR FUTURE USE. UPON INSPECTION IN STORAGE IT WAS DISCOVERED THAT IT HAD LEAKED. NO PATIENT HARM. PATIENT CAME TO CLINIC FOR 5-FU DISCONNECT AND IVF. WHEN PUMP EXAMINED CRYSTALLIZATION NOTED AROUND PUMP AND ON POUCH. THE 5-FU WAS DISCONNECTED WITH 2 ML REMAINING. NO PATIENT HARM. PHARMACIST REPORTED THAT PATIENT'S FLUOROURACIL INFUSION BAG WAS LEAKING AND HAD TO BE REPLACED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690058 WALKMED® BAG, RESERVOIR BTC WALKMED INFUSION LLC 204821

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR CHEMOTHERAPY