BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA

    MDR report key: 681789 · Received March 2, 2006

    Report

    Report Number
    1314492-2006-00002
    Event Type
    Death
    Date Received
    March 2, 2006
    Date of Event
    January 30, 2006
    Report Date
    March 1, 2006
    Manufacturer
    SIGMA INTL.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PATIENT CAME TO THE ER IN 2006 WITH ARTERIAL FIBRILLATION AND CONGESTIVE HEART FAILURE. A CARDIOLOGIST ADMITTED THE PATIENT INTO THE CARDIO VASCULAR UNIT (CVU) AND PLACED HIM ON HEPARIN TO REDUCE THE CHANCE OF SHOWERING BLOOD CLOTS. THE PROTOCOL IS TO TEST THE PTT EVERY 6 HOURS. 2 DAYS LATER THE PATIENT SUFFERED A STROKE. THE PATIENT WAS PLACED ON THE VENTILATOR AT THAT TIME TO SUPPORT HIS AIRWAY. A NURSE EVALUATING THE PTT HAVING NOT ACHIEVED THE THERAPEUTIC RANGE, INSPECTED THE HEPARIN DRIP. WHEN DISCONNECTING THE IV FROM THE PATIENT AND HOLDING IT OVER THE FLOOR NOTICED NO DRIPS OVER A COUPLE OF MINUTES. THE PUMP DOOR WAS OPENED AND AN AIR BUBBLE WAS NOTICED IN THE AREA OF THE PUMPING FINGERS. THE PATIENT WAS REMOVED FROM VENTILATOR AT THE REQUEST OF THE FAMILY AND SUBSEQUENTLY DIED 2/2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA GENERAL PURPOSE INFUSION PUMP FRN SIGMA INTL. SPECTRUM *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death