BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1000362 · Received February 15, 2008

    Report

    Report Number
    MW5005579
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    B BRAUN MEDICAL INC
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WE HAVE COLLECTED REPORTS OF FAILURE OF THE ECLIPSE E251750 DEVICE FROM 11 DIFFERENT PTS AT DIFFERENT SITES OF SERVICE WITHIN OUR COMPANY, BETWEEN SEPTEMBER 2007 AND TODAY. THE DEVICE FAILS TO INFUSE, RESULTING IN A MISSED DOSE. ONE PT REPORTED MULTIPLE DEVICE FAILURES IN A ROW. THE PROBLEMS HAVE BEEN REPORTED TO THE B BRAUN COMPANY AS THEY OCCURRED. THESE DEVICES WERE USED IN THE HOME CARE SETTING. DEFECTIVE DEVICES WERE PICKED UP WHEN POSSIBLE AND EXAMINED B A PHARMACIST. THE DEVICE DID NOT INFUSE WHEN THE SLIDE CLAMP WAS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE ELASTOMERIC DEVICE MEB B BRAUN MEDICAL INC E251750 722198
    2 ECLIPSE ELASTOMERIC DEVICE MEB B BRAUN MEDICAL INC E251750 792499

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other