BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED 152 CM PUMP TUBING SET

    MDR report key: 6968229 · Received October 23, 2017

    Report

    Report Number
    MW5072873
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 19, 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 1,800 MG/M2 (3,500 MG) TO INFUSE OVER 46 HOURS FILLED ON (B)(6) 2017. PHARMACY PREPARED RESERVOIR BAG WITH 70 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. UNABLE TO OBTAIN PUMP READING FROM RN, BUT RESERVOIR BAG APPEARED TO BE COMPLETELY DRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747332 WALKMED 152 CM PUMP TUBING SET WALKMED 152CM PUMP TUBING SET FRN WALKMED INFUSION LLC 20617502

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR