BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED INFUSION AMBULATORY INFUSION PUMP

    MDR report key: 5746495 · Received June 23, 2016

    Report

    Report Number
    1723533-2016-00166
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    May 23, 2016
    Report Date
    May 25, 2016
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WALKMED INFUSION DOES NOT BELIEVE THAT THE EVENT WAS CAUSED BY A FAILURE OF ITS DEVICE, HOWEVER THE DEVICE IN QUESTION IS BEING RETURNED TO WALKMED INFUSION FOR PRODUCT EVALUATION AS A PRECAUTION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION OF THE DEVICE IS COMPLETED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR'S HOTLINE RECEIVED A CALL FROM THE PATIENT'S HUSBAND STATING THAT HIS WIFE HAD HER PUMP PLACED FOUR HOURS PRIOR AND IT WAS ALREADY READING END. THE PUMP WAS NOT DUE TO BE DISCONNECTED FOR ANOTHER TWO DAYS. THE REGISTERED NURSE WENT THROUGH THE PROGRAMMED SETTINGS OVER THE PHONE WITH THE PATIENT AND THE SETTINGS REPORTED WERE A RATE OF 30 ML/HR, VOLUME DELIVERED 139.9 ML, VOLUME LIMIT SET AT 138 ML. THE CALLER CONFIRMED TWICE THAT THE MEDICATION BAG WAS EMPTY. AS REPORTED TO WALKMED INFUSION THE LABEL INFORMATION FOR THE DRUG, FLUOROURACIL, WAS 3960 MG, TOTAL VOLUME OF 138 ML OVER 46 HOURS, RATE 3. THE PUMP WAS STARTED AT APPROXIMATELY 1:30PM. THE HOTLINE NURSE INSTRUCTED THE PATIENT TO STOP THE PUMP AND CALL HER DOCTOR IMMEDIATELY. THE PATIENT WAS HOSPITALIZED AND GIVEN AN ANTIDOTE. WALKMED INFUSION FOLLOWED UP WITH THE CLINIC AND FOUND OUT THE PATIENT IS DOING FINE. THE CLINIC BELIEVES THE PUMP FUNCTIONED AS INTENDED AND THAT THE PUMP'S RATE WAS INADVERTENTLY PROGRAMMED INCORRECTLY (RATE WAS SET AT 30 ML/HR INSTEAD OF 3 ML/HR). THE PUMP IS BEING RETURNED TO WALKMED FOR EVALUATION AS A PRECAUTION.

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE IN QUESTION, WALKMED INFUSION CONFIRMED THE PUMP WAS SET TO A RATE OF 30.00 ML/HR. FURTHER PRODUCT EVALUATION FOUND THE PUMP TO PASS THE DELIVERY ACCURACY TEST AND NO PUMP MALFUNCTION WAS ATTRIBUTABLE TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399462 WALKMED INFUSION AMBULATORY INFUSION PUMP INFUSION PUMP FRN WALKMED INFUSION, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R