BEUDAMED
    FDA Adverse Event Death Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3072282 · Received April 18, 2013

    Report

    Report Number
    1828100-2013-00409
    Event Type
    Death
    Date Received
    April 18, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE SYSTEM FOR A CARDIOPULMONARY BYPASS PROCEDURE (CPB), THE PERFUSION SYSTEM HAD NO AIR SENSOR MODULE, WHICH LEAD TO PATIENT DEAD BY AN EMBOLIC EVENT DUE TO ABSENCE OF AIR SENSOR AND FAILURE OF LEVEL SENSORS. THE SYSTEM WAS NOT CHANGED OUT, AND WAS USED FOR THE SURGERY. PER CLINICAL REVIEW: APPROXIMATELY FIVE MINUTES INTO CPB, THE VENOUS RESERVOIR DRAINED AND AIR ENTERED THE CPB CIRCUIT. IT WAS REPORTED THAT LEVEL SENSORS WERE BEING USED, BUT THEY DID NOT FUNCTION ADEQUATELY. IT WAS ALSO REPORTED THAT AN AIR DETECTOR WAS NOT USED DURING THE PROCEDURE. IT WAS REPORTED THE PATIENT SUFFERED A STROKE, DUE TO AIR EMBOLISM, BUT THEY WERE NOT SURE IF AIR ENTERED THE PATIENT DUE TO DRAINAGE OF THE RESERVOIR OR DURING DE-AIRING OF CPB. THE ARTERIAL PUMP STOPPED AND AIR WAS REMOVED FROM THE CIRCUIT, AFTER THE PATIENT WAS RETURNED TO CPB FOR APPROXIMATELY FIVE MINUTES. THERE WERE ALSO REPORTS OF "FAIL 5/6" MESSAGES ON A ROLLER PUMP THAT RESULTED IN PUMP STOPPAGE AND REQUIRED HAND CRANKING. THE PATIENT EXPIRED IN THE OPERATING ROOM. SURGERY WAS ABOUT THREE HOURS, CPB RAN FOR TWENTY-NINE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168238 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| R CAPIOX CXRX25RE AL8X OXYGENATOR/ARTERIAL FILTER| USED WITHOUT PROBLEM.| TUBE SET TERUMO CXBL032X USED WITHOUT PROBLEM.