BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FUSER 4.7ML/HR 250ML

    MDR report key: 5124175 · Received September 29, 2015

    Report

    Report Number
    MW5056769
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    September 6, 2015
    Report Date
    September 17, 2015
    Manufacturer
    LEVENTON SAU
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FLUORURACIL ADMINISTERED IV VIA LEVENTON 4.7ML/HR 250ML PORTABLE ELASTOMERIC INFUSOR OVER A 46 HR PERIOD. AT END OF INFUSION, PT PRESENTED AT CLINIC WITH WET INFUSER BAG AND CLOTHING. THE INFUSER SYSTEM HAD APPARENTLY LEAKED. CRYSTALS APPEARED WHERE DRUG LEAK HAD EVAPORATED. LARGEST AMOUNT APPEARED AT THE SEAM ON "CAPILLARY ELEMENT" (A. K. A. "RESTRICTER ELEMENT").

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642145 DOSI-FUSER 4.7ML/HR 250ML PORTABLE ELASTOMERIC INFUSER MEB LEVENTON SAU 150337L

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR