BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    152 CM WALKMED PUMP TUBING SET

    MDR report key: 7002885 · Received November 6, 2017

    Report

    Report Number
    MW5073143
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 25, 2017
    Report Date
    November 2, 2017
    Manufacturer
    WALKMED INFUSION LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT HAD ORDER FOR 5FU 1,100 MG/M2 (2950 MG) VIA CONTINUOUS INFUSION OVER 46 HOURS FILLED ON (B)(6) 2017. PHARMACY PREPARED RESERVOIR BAG WITH 59 ML + 3 ML OVERFILL 5-FU 50 MG/1 ML PER NORMAL PROCEDURE. WHEN PT RETURNED ON (B)(6) 2017 FOR PUMP DISCONNECT, INFUSION RN NOTED SMALL AIR BUBBLES IN TUBING BETWEEN RESERVOIR BAG AND WALKMED INFUSION PUMP. PUMP READING INDICATED 59.1 ML HAD INFUSED, AND RESERVOIR BAG APPEARED TO BE COMPLETELY DRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784305 152 CM WALKMED PUMP TUBING SET 152 CM WALKMED PUMP TUBING SET FRN WALKMED INFUSION LLC 20617502

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR