BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENOUS BLOODLINE FOR FRES 2008;GAMBRO-A

    MDR report key: 237793 · Received August 30, 1999

    Report

    Report Number
    8030665-1999-00247
    Event Type
    Death
    Date Received
    August 30, 1999
    Date of Event
    July 23, 1999
    Report Date
    July 26, 1999
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VENOUS DISCONNECT WAS REPORTED FROM AN ASH MEDCOMP INTERJUGULAR PERMEATH CATHETER FROM CLINICAL SERVICES. "DSD" REPORTS THAT TWO HOURS INTO ROUTINE HEMODIALYSIS TREATMENT, THE PT WAS FOUND UNCONSCIOUS. THE VENOUS LINE WAS FOUND SEPARATED FROM THE CATHETER. THERE WAS VISIBLE BLOOD ON THE FLOOR, ESTIMATED BLOOD LOSS ? THE VENOUS LINE WAS RECONNECTED, BLOOD WAS RETURNED, AND 600CC OF NORMAL SALINE WAS ADMINISTERED. THE PT WAS TRANSPORTED TO THE HOSPITAL AND EXPIRED. FOLLOW-UP CONVERSATION TRANSPIRED ON 7-27-99 WITH DIRECTOR OF NURSING. THE CONVERSATION WAS TO VERIFY AND OBTAIN ADDITIONAL INFO. DIRECTOR OF NURSING INDICATES THAT THE VENOUS LINE WAS FOUND SEPARATED FROM THE CATHETER AND LYING UNDER THE PT'S ARM. PT INFO WAS RECEIVED. CLINIC INDICATED THAT CATHETER WAS 1 MONTH OLD. SAMPLE IS AVAILABLE. USER FACILITY MDR WAS FILED AGAINST THE BLOODLINE, THE CATHETER AND THE DIALYSIS MACHINE. USER FACILITY MDR WAS RECEIVED AFTER CONVERSATION WITH DIRECTOR OF NURSING ON 7-27-99. THE BLOODLINE USER FACILITY MDR INDICATES THAT A VENOUS LINE SEPARATION OCCURRED WITH APPROX 1.5 X 2 FT OF BLOOD FOUND ON THE FLOOR. INDICATES THAT THE CAUSE OF THE DISCONNECT IS UNK. AIRBORNE MAILER WAS SENT ON 7-27-99 WITH RESPONSE LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE FOR FRES 2008;GAMBRO-A BLOODLINE FJK ERIKA DE REYNOSA NA R9B045

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death 2008H, F80 2ND REUSE WITH FORMALIN.