BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED 350VL INFUSION PUMP

    MDR report key: 7063485 · Received November 28, 2017

    Report

    Report Number
    MW5073587
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    November 22, 2017
    Report Date
    November 22, 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 CONTINUOUS INFUSION 2.400 MG/M2 (5,650 MG) TO INFUSE OVER 46 HOURS AT 2.46 ML/HR FILLED ON (B)(6) 2017. PHARMACY FILLED BAG WITH 113 ML + 3 ML OVERFILL 5FU 50 MG/1 ML PER NORMAL PROCEDURE. WHEN PT RETURNED ON (B)(6) 2017 FOR PUMP DISCONNECT, INFUSION RN (CH) NOTED RESERVOIR BAG IN WALKMED 350VL INFUSION PUMP STILL HAD A SIGNIFICANT AMOUNT (MEASURED BY PHARMACY TO BE 35.0 ML) STILL IN BAG. PT REPORTED NO ALARM HAD SOUNDED, AND PUMP NEVER STOPPED VIBRATING. GREEN LIGHT ON PUMP STILL FLASHING. PUMP READING INDICATED 113.8 ML HAD INFUSED. FILL VOLUME OF 116 ML CONFIRMED BY RPH AFTER REVIEWING PREPARATION PICTURES IN DOSE EDGE. NO AIR BUBBLES IN TUBING THAT CONNECTED RESERVOIR BAG TO THE INFUSION PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842000 WALKMED 350VL INFUSION PUMP AMBULATORY CONT. INFUSION PUMP FRN WALKMED INFUSION LLC 350VL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR