BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED INFUSION PUMP, RESERVOIR BAG

    MDR report key: 9369051 · Received November 22, 2019

    Report

    Report Number
    MW5091275
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    November 13, 2019
    Report Date
    November 14, 2019
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH 5-FLUOROURACIL WALKMED INFUSION PUMP SENT HOME FOR 46 HOUR INFUSION EXPERIENCED LEAK OF CHEMOTHERAPY AT INFUSION BAG AND TUBING CONNECTION. PATIENT HAD TO DISCONNECT FROM INFUSION AFTER THE CHEMOTHERAPY LEAKED ON CLOTHING. PUMP WAS FILLED WITH LEAKING 5-FLUOROURACIL AND WAS BROUGHT TO THE CHEMOTHERAPY INFUSION CLINIC IN A PLASTIC BAG. FANNY PACK THAT CARRIED INFUSION WAS SOAKED WITH THE LEAKING 5-FLUOROURACIL. TUBING AND BAG MANUFACTURER CONTACTED TO REPORT INCIDENT - POSSIBLE LOT NUMBER OF BAG RESERVOIR IS 20119503 OR 20319509 AND POSSIBLE TUBING LOT NUMBER 20219501. · CHEMOTHERAPY SPILL, SUSPECT DRUG# 1, DOSING: AS CONTINUOUS INFUSION OVER 46 HOURS EVERY 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157615 WALKMED INFUSION PUMP, RESERVOIR BAG PUMP, INFUSION FRN WALKMED, LLC
    1157616 WALKMED TUBING PUMP, INFUSION FRN WALKMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other