BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED INFUSION PUMP

    MDR report key: 9369052 · Received November 22, 2019

    Report

    Report Number
    MW5091276
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    October 31, 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

    PT WITH 5-FLUOROURACIL CONTINUOUS WALKMED INFUSION PUMP RETURNED TO THE CHEMOTHERAPY INFUSION CLINIC WITH FANNY BAG WET WITH WHITE RESIDUE. PT REPORTS THAT HE NOTICED RESIDUE ON FANNY BAG ON (B)(6) 2019 AT 21:00 BUT DID NOT REPORT TO NURSE. HE STATES NO RESIDUE HAS GOTTEN ON HIMSELF. PUMP, RESERVOIR BAG, AND TUBING WERE INSPECTED. INSPECTION REVEALED WHAT LOOKED LIKE A CRACKED MALE LINE CONNECTION ON BAG PORTION; 5-FLUOROURACIL WAS FOUND TO BE IN PUMP INCASING. NO LOT NUMBER AVAILABLE ON EITHER RESERVOIR BAG OR TUBING (ONLY ON OUTSIDE PACKAGING WHICH WAS ALREADY DISCARDED). CHEMOTHERAPY SPILL, SUSPECT DRUG #1, DOSING: CONTINUOUS INFUSION OVER 48 HOURS EVERY 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157614 WALKMED INFUSION PUMP PUMP, INFUSION FRN WALKMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other