BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOSI-FUSER

    MDR report key: 2132601 · Received June 13, 2011

    Report

    Report Number
    MW5020982
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    LEVENTON, S.A.U.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DOSI-FUSER 250ML 2 DAY PUMP -4.7ML/HOUR-, A PORTABLE ELASTOMERIC INFUSER MANUFACTURED BY LEVENTON AND DISTRIBUTED BY (B)(4), WAS FILLED WITH NORMAL SALINE AND FLUOROURACIL AND CONNECTED TO THE PT ON (B)(6) 2011. THE NEXT DAY, THE PT REPORTED THAT THE INFUSER WAS LEAKING ALL OVER CLOTHING. WHEN THE PT RETURNED TO THE CLINIC, THE NURSE REALIZED THAT THE FLUID WAS LEAKING FROM THE CAPILLARY ELEMENT, ALSO REFERRED TO AS THE "SENSOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOSI-FUSER PORTABLE ELASTOMERIC INFUSER MEB LEVENTON, S.A.U. 110442L

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| S