BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALINES ARTERIAL AND VENOUS BLOOD TUBING SET

    MDR report key: 575011 · Received February 18, 2005

    Report

    Report Number
    9616074-2005-00002
    Event Type
    Injury
    Date Received
    February 18, 2005
    Date of Event
    January 17, 2005
    Report Date
    January 20, 2005
    Manufacturer
    MEDISYSTEMS CORPORATION
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR 4 HOUR HEMODIALYSIS TREATMENT. TWO HOURS INTO TREATMENT CIRCUIT DISCARDED DUE TO CLOTTING IN THE EXTRACORPOREAL CIRCUIT. A NEW SYSTEM WAS SET UP. TREATMENT TERMINATED AFTER 30 MIN. DUE TO CLOTTING IN THE EXTRACORPOREAL CIRCUIT. ELB = 500 CC. PATIENT'S GRAFT ACCESS REQUIRED DECLOTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALINES ARTERIAL AND VENOUS BLOOD TUBING SET HEMODIALYSIS BLOOD TUBING SET FJK MEDISYSTEMS CORPORATION NA 4105102

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other