BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FUSER

    MDR report key: 6935897 · Received October 10, 2017

    Report

    Report Number
    MW5072667
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 15, 2017
    Report Date
    October 5, 2017
    Manufacturer
    LEVENTON/OMNI MEDICAL SUPPLY
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT HAD CHEMOTHERAPY (FLUOROURACIL) IN A DOSI-FUSER AMBULATORY PUMP, AND WHEN SHE CAME IN TO HAVE PUMP DISCONNECTED, IT WAS NOTICED THAT THE FLUOROURACIL HAD LEAKED THROUGH THE CAPILLARY MECHANISM OF THE PUMP. IT WAS UNK HOW MUCH DOSE PT HAD RECEIVED AND HOW MUCH LEAKED OUT FOR THE PRIOR 2 DAYS. MFR OF THE PUMP IS LEVENTON, AND DISTRIBUTOR IS OMNI MEDICAL SUPPLY. APPARENTLY OMNI KNEW THAT THIS PARTICULAR LOT/PUMP HAD PROBLEMS, BUT OUR FACILITY WAS NOT NOTIFIED OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718897 DOSI-FUSER DOSI-FUSER MEB LEVENTON/OMNI MEDICAL SUPPLY L25915-150D2-USA 170500L

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other