BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIPRO SET BLOOD TUBING LINE

    MDR report key: 1572271 · Received January 6, 2010

    Report

    Report Number
    1056186-2009-00003
    Event Type
    Death
    Date Received
    January 6, 2010
    Date of Event
    November 17, 2009
    Report Date
    December 2, 2009
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS ADMITTED WITH PAIN AND POOR CIRCULATION IN HIS RIGHT ARM AND AN ADMITTING DIAGNOSIS OF ABNORMAL REACTION GRAFT. THE PATIENT HAD COMPLETED THERAPY AND RETURNED TO THE UNIT. PRE-HEMODIALYSIS LABS HAD BEEN DRAWN ON THE DAY OF THE EVENT THAT INDICATED HEMOLYSIS. THE PATIENT WAS ALERT, ORIENTED AND TALKING DURING THERAPY. THE PATIENT WAS ASYMPTOMATIC DURING THERAPY. APPROXIMATELY 30 MINUTES AFTER HIS RETURN TO THE HOSPITAL UNIT, THE NURSE FOUND THE PATIENT MOANING AND NON-RESPONSIVE. THE RAPID RESPONSE TEAM WAS CALLED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AT 1300. A CHEMISTRY WAS DRAWN DURING THE CODE WHICH INDICATED HEMOLYSIS. THE PATIENT DID NOT RESPOND TO RESUSCITATION MEASURES AND THE CODE WAS CALLED AT 1337. THE LISTED CAUSE OF DEATH WAS RESPIRATORY DISTRESS, END STAGE RENAL DISEASE (ESRD) AND BLOOD CLOT. AN AUTOPSY WAS NOT AND WILL NOT BE PERFORMED. REPORTEDLY, THIS WAS A NON-COMPLIANT PATIENT. THE MEDICAL DIRECTOR INDICATED HE DID NOT FEEL THE TINA DIALYSIS MACHINE, FRESENIUS DIALYZER OR THE NIPRO BLOOD LINES WERE IMPLICATED IN THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO SET BLOOD TUBING LINE BLOODLINE FJK NIPRO MEDICAL CORPORATION A216V805 08I27

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death