BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA MODEL SPECTRUM

    MDR report key: 2070229 · Received April 26, 2011

    Report

    Report Number
    1314492-2011-00012
    Event Type
    Death
    Date Received
    April 26, 2011
    Date of Event
    February 14, 2011
    Report Date
    April 26, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIGMA WAS UNABLE TO ASCERTAIN THE CIRCUMSTANCES FOLLOWING THE REPORTED EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S DEATH. A RESPONSE FROM THE BIOMEDICAL ENGINEERING DEPARTMENT OF (B)(6) HOSPITAL INDICATED THAT IN HOUSE TESTING CONDUCTED COULD NOT DUPLICATE THE PROBLEM. THE RESULT OF (B)(6) HOSPITAL'S BIOMEDICAL ENGINEERING DÉPARTEMENT CONCLUDED THAT THE PUMP PERFORMED AS DESIGNED. SIGMA RECEIVED THE DEVICE ON (B)(6) 2011. THE PUMP'S HISTORY LOG WAS REVIEWED. THE EVAL OF THE VTBI OVER THE HOURS LEADING TO THE EVENT SHOWED VARYING VTBI ASSOCIATED WITH SEVERAL 250 ML BAGS OF NOREPINEPHRINE. THE CUMULATIVE TOTAL OF VTBI PROGRAMMED EXCEEDED THE TOTAL THAT WOULD HAVE BEEN AVAILABLE FROM FIVE BAGS OF NOREPINEPHRINE. THE HISTORY LOG SHOWED THAT ONE MINUTE AFTER THE REPORT THAT THE PT ARRESTED, THE PUMP ALARMED FOR AIR IN LINE. TESTING AT SIGMA INCLUDED A REPLICATION OF THE DELIVERY PROFILE FROM THE DEVICE'S HISTORY LOG. THE PUMP PERFORMED TO SPEC. THE PUMP DETECTED "AIR IN LINE" PER SPEC, THE AUDIBLE ALARM TONE OPERATED AND INCREMENTED IN VOLUME AS DESIGNED AND THE FLOW RATE ACCURACY WAS WITHIN SPEC. THE PUMP PASSED STANDARD UPSTREAM OCCLUSION AND FLOW RATE TESTING. SIGMA WAS ABLE TO VERIFY THAT THE PUMP ALARMED "AIR IN LINE" ONE MINUTE AFTER THE EVENT WAS SAID TO OCCUR. SIGMA FOUND NO DEVICE MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS RECEIVED FROM MEDWATCH REPORT (B)(4). THE MEDWATCH REPORT INDICATED THE OUTCOME OF THE ADVERSE EVENT AS LIFE-THREATENING AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE PT WAS HIT BY A PLOW TRUCK SUSTAINING MULTIPLE INJURIES. HE REQUIRED THE USE OF MULTIPLE CARDIAC MEDICATIONS. HE STARTED TO LOSE BLOOD PRESSURE AND BRADIED (BRADYCARDIA) INTO THE TEENS AND WENT INTO CARDIAC ARREST. THE CLINICIAN NOTED HIS NOREPINEPHRINE WAS DRY BUT THE IV PUMP WAS NOT ALARMING. HAD THE PUMP ALARMED WHEN IT DETECTED AIR, A NEW BAG OF NOREPINEPHRINE COULD HAVE BEEN HUNG IN TIME. SIGMA'S F/U WITH THE CLINICIAN DETERMINED AT SOME POINT AFTER THE EVENT OCCURRED, THE PT DIED FROM CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA MODEL SPECTRUM SPECTRUM INFUSION PUMP FRN SIGMA LLC 35700 782601

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| R