BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPLEGIA DELIVERY SETS

    MDR report key: 1070514 · Received July 1, 2008

    Report

    Report Number
    6000002-2008-07851
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 25, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WAS FOUND TO BE NON-FUNCTIONING, AND THERE WAS IMPASSABILITY IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA SETS DWF EDWARDS LIFESCIENCES CDS004S 58429908

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK