BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 8000 VOLUMETRIC INFUSION PUMP

    MDR report key: 106082 · Received July 15, 1997

    Report

    Report Number
    1314492-1997-00006
    Event Type
    Death
    Date Received
    July 15, 1997
    Date of Event
    June 13, 1997
    Report Date
    June 24, 1997
    Manufacturer
    SIGMA INTL.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    64 YR OLD FEMALE WITH HISTORY OF CHRONIC AFIB, AORTIC/MITRAL VALVE REPLACEMENT 1/96 WITH PROGRESSIVE RECURRENT PLEURAL EFFUSIONS ADMITTED 6/6/97 TO TREAT EFFUSIONS. HOSP COURSE INCLUDED THORACENTESIS, HEART CATH, MED TREATMENT. 6/12, PT UNDERWENT THORACOTOMY WITH DECORTICATION. SHORTLY AFTER SURGERY, PT MANIFESTED CARDIOGENIC SHOCK REQUIRING SWAN GANZ PLACEMENT, DOPAMINE, DOBUTAMINE AND EPINEPHRINE DRIPS. APPROX 5 HRS AFTER PRESSURE DROP, HEPARIN DRIP ORDERED AS ANTICOAGULATION PROPHYLAXIS FOR CLOTS. DURING NEXT 8 HRS DESPITE DIRECT HEPARIN BOLUSES AND HEPARIN INFUSION PER SIGMA PUMP, ANTICOAGULATION NOT ACHIEVED. AFTER 8 HRS HEPARIN BAG REMAINED FULL DESPITE NO PUMP ALARMING. PT EXPIRED 2 DAYS LATER DUE TO MULTIPLE SYSTEM FAILURE. TWO ATTENDING PHYSICIANS FEEL PERIOD OF INADEQUATE ANTICOAGULATION NOT RELATED TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 8000 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN SIGMA INTL. 8000 SIGMA *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other