BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 2398365 · Received January 4, 2012

    Report

    Report Number
    2937457-2011-00024
    Event Type
    Death
    Date Received
    January 4, 2012
    Date of Event
    October 15, 2011
    Report Date
    November 21, 2011
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MACHINE INVESTIGATION BY THE REG EQUIPMENT SPECIALIST (RES) WAS CONDUCTED AND IT WAS DETERMINED THAT A UF VARIANCE OF APPROX 50 -60 ML/HR EXISTED. THE UF VARIANCE OF 240 ML WITH THE SET UF GOAL OF 3 KG OVER A 4 HOUR TREATMENT TIME IS NOT SIGNIFICANT TO ADVERSELY AFFECT THE PT. (B)(4).

    Description of Event or Problem · 1

    THE PT WAS HEMODIALYZING IN THE HOSP AND RECEIVING 4 UNITS OF PACKED RED BLOOD CELLS (RBCS) AS A RESULT OF GROSS RECTAL BLEEDING. HER BLOOD PRESSURE (BP) WAS VERY LOW (89/43) FROM THE BEGINNING AND HER DR, DR (B)(6) WAS AWARE. THE NURSE DID NOT SET THE HEMODIALYSIS MACHINE TO REMOVE EXCESS FLUID BECAUSE OF THE LOW BP, HOWEVER, THE MACHINE WAS SET TO REMOVE 150 ML/HR FOR THE 4 HOUR TREATMENT PERIOD. HER DIALYZER AND VENOUS BLOODLINES CLOTTED ABOUT HALF WAY THROUGH THE THIRD UNIT OF RBCS; SHE WAS NOT RECEIVING ANY HEPARIN. THE NURSE HAD RETURNED THE PT'S BLOOD SO THAT THE DIALYZER AND BLOOD LINES COULD BE REPLACED TO ALLOW THE PT TO RECEIVE THE REMAINING UNIT OF BLOOD AND COMPLETE HER TREATMENT. WHEN THE NURSE STARTED UNHOOKING THE PT FROM THE BLOODLINES, SHE NOTICED THE PT'S EYES ROLLING TO THE BACK OF HER HEAD. THE PT TOOK A REALLY DEEP BREATH, THE NURSE CALLED THE PT'S NAME SEVERAL TIMES BUT SHE DID NOT RESPOND. THE FLOOR NURSE WAS NOTIFIED AND A CODE WAS INITIATED. CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED UNTIL THE RESPONSE TEAM ARRIVED. THE PT WAS UNABLE TO BE RESUSCITATED AND SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death