BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYPUMP ELASTOMERIC INFUSION PUMP

    MDR report key: 10573887 · Received September 22, 2020

    Report

    Report Number
    MW5096817
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    September 18, 2020
    Report Date
    September 21, 2020
    Manufacturer
    B BRAUN MEDICAL INDUSTRIES SDN. BHD.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED ON (B)(6) 2020 FOR FOLFOX CHEMOTHERAPY. THE 46-HOUR TAKE HOME FLUOROURACIL DOSE WAS COMPOUNDED IN A B BRAUN EASYPUMP ELASTOMERIC DEVICE (270-54-S). THE CORRECT DRUG, THE CORRECT DRUG AND BASE SOLUTION VOLUME AND CORRECT SIZE/RATE ELASTOMERIC DEVICE WAS USED TO PREPARE THE 5FU DOSE FOR THIS PATIENT AS CONFIRMED IN THE COMPOUNDING CAMERA IMAGES. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 WITH RECTAL BLEEDING. LAB TESTS RESULTED PLT OF 9. AT 4PM ON (B)(6) 2020, IT WAS ALSO NOTED IN THE HOSPITALIZATION RECORD THAT THE ELASTOMERIC DEVICE WAS EMPTY. THE ELASTOMERIC DEVICE CONTAINING CHEMOTHERAPY SET TO INFUSE OVER 46 HOURS WAS ATTACHED ON (B)(6) 2020 AT 1148AM. THE DEVICE HAS AN ACCURACY OF INFUSION DURATION +/- 15% AND SHOULD HAVE ENDED BETWEEN 448AM AND 348PM ON (B)(6) 2020. THE ELASTOMERIC RAN TO FAST AND EMPTIED 11 HOURS EARLY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035810 EASYPUMP ELASTOMERIC INFUSION PUMP PUMP, INFUSION, ELASTOMERIC MEB B BRAUN MEDICAL INDUSTRIES SDN. BHD. II LT 270-54-S 20C10GE561

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization