BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS

    MDR report key: 378475 · Received February 25, 2002

    Report

    Report Number
    378475
    Event Type
    Injury
    Date Received
    February 25, 2002
    Date of Event
    January 15, 2002
    Report Date
    February 11, 2002
    Manufacturer
    FRESENIUS MEDICAL CARE AG
    Product Code
    KDL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FRESENIUS KIDNEY PERFUSION SET WITHOUT-AIR-VENT MALFUNCTIONED WHILE PERFUSING TRANSPLANT KIDNEY IN PREPARATION OF IMPLANTATION INTO RECIPIENT. THE NURSE NOTICED FLUID LEAKING FROM THE CONNECTION BETWEEN THE WHITE TIP AND THE CLEAR TUBING. THE SURGEON ADAPTED THE TUBING TO STOP THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS KIDNEY PERFUSION TUBE KDL FRESENIUS MEDICAL CARE AG * KK1076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention