BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FLOW

    MDR report key: 3042432 · Received February 6, 2013

    Report

    Report Number
    9611707-2013-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 28, 2012
    Manufacturer
    LEVENTON S.A.U.
    Product Code
    FPA
    PMA / PMN Number
    K952810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN TREATED IN (B)(6). AS AN INCIDENCE (B)(4), BY ASSESSING THE SAMPLES CORRESPONDING TO THE INVOLVED BATCH NUMBER. THE MAUDE EVENT REPORT NUMBER IS (B)(6).

    Description of Event or Problem · 1

    THE PT WAS USING AN I.V. FLOW REGULATOR WITH 20-DROP/ML ADULT SET (DOSI-FLOW 30 DISTRIBUTED BY VICTUS INC) TO INFUSE ANTIBIOTICS IN THE HOME FOR TREATMENT OF OSTEOMYELITIS. SEVERAL PRODUCTS WERE OBSERVED TO BE DEFECTIVE SINCE THE FLOW WAS MUCH SLOWER THAN THE RATE SET ON DIAL (OR EVEN NO FLOW EXISTED), TO THE EXTENT THAT THE PT HAD TO INCREASE THE RATE ON DIAL UP TO "OPEN" POSITION TO GET IT TO FLOW. THE PT WAS ADVISED NOT TO USE OTHER PRODUCTS WITH LONGER TUBING, AS FLOW RATE COULD NOT BE ADEQUATELY CONTROLLED BY DIAL AND THEREFORE, IT WOULD NOT BE SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51666 DOSI-FLOW INTRAVASCULAR ADMINISTRATION SET (FPA) FPA LEVENTON S.A.U. L2590263-VICTUS 111667L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other