BEUDAMED
    FDA Adverse Event Death Summary report: N

    U1105 S1000 TINA HD WITH HIBP

    MDR report key: 1221044 · Received November 4, 2008

    Report

    Report Number
    1423500-2008-00887
    Event Type
    Death
    Date Received
    November 4, 2008
    Date of Event
    October 18, 2008
    Report Date
    October 18, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKP
    PMA / PMN Number
    K910215
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN MADE AN ON SITE VISIT IN 2008 TO EVALUATE THE DEVICE. A FULL FUNCTIONAL CHECK WAS PERFORMED AND ALL ITEMS WERE WITH SPECIATION. THE MACHINE WAS FOUND TO BE FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    IN 2008, THE BAXTER FIELD SERVICE REPRESENTATIVE REPORTED THE FACILITY CALLED TO REPORT THAT A PT DEATH HAD OCCURRED ON THE SAME DAY, WHILE THE PT WAS ON A TINA HEMODIALYSIS INSTRUMENT. REPORTEDLY, THE TINA MACHINE BEGAN TO ALARM WITH A PRESSURE ALARM WHEN THE BLOOD PRESSURE (BP) BEGAN TO DROP (LEVEL UNKNOWN). NO OTHER PROBLEMS WERE NOTED WITH THE MACHINE. AT 0700 ON THAT DAY, THE PATIENT'S BLOOD PRESSURE WAS 134/46. AT 0730, THE MACHINE ALARMED AND THE PT WAS NOTED TO BE PALE AND UNRESPONSIVE. THE FACILITY STAFF INITIATED CARDIO PULMONARY RESUSCITATION (CPR) AND THE HOSPITAL CODE TEAM ASSISTED. THE PT EXPIRED LATER THAT DAY. THIS WAS A FEMALE PT RECEIVING HEMODIALYSIS THERAPY ON A TINA MACHINE AT THE DIALYSIS CENTER. THE LISTED CAUSE OF DEATH IS CARDIAC ARREST. AN AUTOPSY WAS NOT PERFORMED. NO LABS OR SCANS WERE ORDERED AS PART OF THE EVENT. THE PATIENT HAS A HISTORY OF CONGESTIVE HEART FAILURE (CHF) AND A NEW PACEMAKER WAS RECENTLY INSERTED. REPORTEDLY, THE PHYSICIAN INDICATED THAT THE PACEMAKER MIGHT NOT HAVE BEEN WORKING PROPERLY. THERE IS NO ALLEGATION AGAINST THE INSTRUMENT. AN ON SITE VISIT WAS OFFERED BUT DECLINED BY THE NURSE MGR. ARRANGEMENTS HAVE BEEN MADE FOR THE FIELD SERVICE ENGINEER (FSE) TO VISIT THE FACILITY AND EVALUATE THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death