BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTI-FLOW DOUBLE LUMEN LONG-TERM CATHETER

    MDR report key: 487572 · Received October 2, 2003

    Report

    Report Number
    487572
    Event Type
    Death
    Date Received
    October 2, 2003
    Date of Event
    December 10, 2002
    Report Date
    April 16, 2003
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS FORM IS FILED IN FOLLOW-UP TO TELEPHONE REPORTS OF THE INCIDENT. TWO AND A HALF HOURS INTO AN OTHERWISE NORMAL DIALYSIS PROCEDURE, THE VENOUS RETURN CATHETER CONNECTOR ON A DOUBLE LUMEN CATHETER WAS FOUND TO HAVE DISCONNECTED. PT EXPIRED DUE TO THE BLOOD LOSS. THE PT AND CATHETER WERE COVERED WITH A BLANKET DURING THE PROCEDURE SO THE DISCONNECTION WAS NOT NOTICED UNTIL THE PT'S CONDITION DETERIORATED PAST THE POINT OF SALVATION. AT THE SAME TIME THE PT'S CONDITION WAS NOTICED BY OTHERS TO BE DETERIORATING, THE ARTERIAL LOW PRESSURE LIMIT ON THE DIALYSIS MACHINE ALARMED. THE DISCONNECTION WAS NOTICED MINUTES AFTER PT RECEIVED A HUG FROM THEIR FATHER. AT THE TIME OF THE HUG, THE DIALYSIS MACHINE ALARMED, PROBABLY DUE TO PT MOVEMENT, AND THE HUG WAS TERMINATED. BESIDES THE MOVEMENT AND ARTERIAL LOW PRESSURE ALARMS, IT IS REPORTED THAT THE DIALYSIS MACHINE DID NOT ALARM FOR ANY OTHER REASON. NO VENOUS LINE LOW PRESSURE ALARM SOUNDED. IT IS ALSO NOTED THAT AFTER THE HUG THE PT WAS LAYING ON THEIR SIDE, BUT WHEN THE LINE WAS FOUND DISCONNECTED PT WAS LAYING ON THEIR BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FLOW DOUBLE LUMEN LONG-TERM CATHETER HEMODIALYSIS CATHETER MSD BARD ACCESS SYSTEMS OPTI-FLOW UNK
    2 DIALOG DIALYSIS MACHINE MSD B BRAUN MEDICAL, RENAL THERAPIES DIVISION DIALOG *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death