BEUDAMED
    FDA Adverse Event Death Summary report: N

    U1105 S1000 TINA HD WITH NIBP

    MDR report key: 1100484 · Received August 4, 2008

    Report

    Report Number
    1423500-2008-00714
    Event Type
    Death
    Date Received
    August 4, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKP
    PMA / PMN Number
    K910215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WENT ON-SITE TO EVALUATE THE MACHINE. A FOLLOW-UP REPORT WILL BE FIELD UPON COMPLETION OF THE EVAL OR IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BAXTER RECEIVED NOTIFICATION IN 2008, THAT A PT EXPIRED WHILE RECEIVING A DIALYSIS TREATMENT ON A TINA HEMODIALYSIS MACHINE. THE MALE PT HAS A HISTORY OF SEIZURES. APPROXIMATELY TWO AND ONE HALF HOURS INTO THE TREATMENT, THE PT EXPERIENCED A SEIZURE AND EXPIRED. THERE IS NO REPORTED MALFUNCTION OF THE DEVICE AND THERE WERE NO REPORTED ALARMS. HE WAS AWAKE AND ALERT AT 1:00 PM BUT WAS UNRESPONSIVE AT 1:10 PM AND EXPIRED AT 1:16 PM ON THE EVENT DATE. THE PT WAS ADMITTED TO THE HOSPITAL TWO DAYS PRIOR, TO RULE OUT MYOCARDIAL INFARCTION. HE HAS HAD SEIZURES DURING DIALYSIS IN THE PAST. HE WAS BEING TREATED FOR A SEIZURE DISORDER. DURING DIALYSIS, THE PT RECEIVED HEPARIN 3000 UNITS (APP PHARMACEUTICALS) AND 500 ML OF SALINE. THE PT HAD A "DO NOT RESUSCITATE" ORDER. THERE WILL BE NO AUTOPSY PERFORMED. NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U1105 S1000 TINA HD WITH NIBP 78FKP FKP BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death