BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMBI-SET HEMODIALYSIS BLOOD TUBING SET

    MDR report key: 434466 · Received December 24, 2002

    Report

    Report Number
    434466
    Event Type
    Death
    Date Received
    December 24, 2002
    Date of Event
    December 18, 2002
    Report Date
    December 23, 2002
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN KIDNEY DIALYSIS UNIT FOR HEMODIALYSIS RUN. DIALYSIS ACCESS WAS A RIGHT INTERNAL JUGULAR VENOUS CATHETER. PT HAD A 4-YEAR PROGRESSIVE HISTORY OF RENAL INSUFFICIENCY SECONDARY TO AN ILL-DEFINED CHRONIC GLOMERULOSCLEROSIS. PT WAS NOT FELT TO BE MAKING ANY PROGRESS DESPITE INTERVENTIONS. ALSO WITH HISTORY OF HYPERTENSION AND A SEIZURE DISORDER. APPROX 25 MINUTES INTO THE DIALYSIS RUN, A LARGE QUANTITY OF BLOOD NOTED FROM THE RIGHT INTERNAL JUGULAR CATHETER VENOUS LIMB LUER LOCK CONNECTION WHILE USING "COMBI SET HEMODIALYSIS BLOOD TUBING SET WITH PRIMING SET AND TRANSDUCER PROTECTORS". NO WARNING ALARMS SOUNDED. PT EXPERIENCED HYPOTENSION AND DECREASED RESPONSIVENESS. PT WAS SUCCESSFULLY RESUSCITATED WITH FLUID ADMINISTRATION. APPROX ONE HOUR LATER, THE PT EXPIRED. THE PT AND FAMILY HAD PREVIOUSLY EXPRESSED A DESIRE FOR NO AGGRESSIVE MEASURES IN FACE OF A CARDIOPULMONARY ARREST. CAUSE OF DEATH IS NOT KNOWN. THE PHYSICIAN INDICATES HE FEELS THIS EPISODE DID NOT DIRECTLY CAUSE PT'S DEATH BUT NOTED THAT THIS WAS "THE FINAL NAIL IN THE COFFIN". KIDNEY DIALYSIS UNIT NURSE MGR REPORTS THE KIDNEY DIALYSIS UNIT NURSES ARE REPORTING FOUR OTHER PTS WHO EXPERIENCED BLEEDING FROM VENOUS LIMB CATHETER LUER LOCK CONNECTIONS DURING DIALYSIS WHILE USING "COMBI-SET HEMODIALYSIS BLOOD TUBING SET," A PRODUCT PROVIDED BY FRESENIUS MEDICAL CARE. THIS PROBLEM HAS BEEN NOTED WITH BOTH CATHETERS AND NEEDLES. LOT NUMBERS OF THE COMBI-SETS FOR THE ABOVE NOTED FOUR PTS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBI-SET HEMODIALYSIS BLOOD TUBING SET WITH PRIMING SET & TRANSDUCER PROTECTORS FJK FRESENIUS MEDICAL CARE NORTH AMERICA 03 2622-3 2NR 209

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death