BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVENTON

    MDR report key: 813442 · Received February 6, 2007

    Report

    Report Number
    MW1041896
    Event Type
    Malfunction
    Date Received
    February 6, 2007
    Report Date
    February 6, 2007
    Manufacturer
    LEVENTON
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WE HAD MULTIPLE PRODUCT FAILURE WITH THE DOSI-FUSER INFUSION DEVICE, MADE BY LEVENTON AND DISTRIBUTED BY HOSPIRA. THEIR CATALOG NUMBER IS: 2072301. IT IS THE 150ML 2 DAY INFUSER. WE HAD 4 INFUSERS THAT LEAKED AT THE JOINT BETWEEN THE TUBING AND FILTER. IT DID NOT EFFECT THE PT IN ANY INSTANCE, AS IT WAS DISCOVERED PRIOR TO EYER BEING HOOKED UP FOR DRUG INFUSION. ALL PRODUCT FAILURES WERE CONFINED TO LOT # 061817L. DEVICE FAILURE WAS REPORTED TO HOSPIRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVENTON DOSI-FUSER FPA LEVENTON 25915-150D2 061817L

    Patients

    Seq Age Sex Outcome Treatment
    1 *