BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 8599475 · Received May 10, 2019

    Report

    Report Number
    9681834-2019-00074
    Event Type
    Death
    Date Received
    May 10, 2019
    Date of Event
    April 21, 2019
    Report Date
    May 10, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - REQUESTED, NOT YET PROVIDED. 510(K) - K130520. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE WAS USED DURING A CARDIAC SURGERY. THE DEATH OF THE PATIENT WAS DUE TO THE OXYGENATOR FAILURE. THE HOSPITAL SAID IT WAS "DU" IT WORKED FOR 90 MINUTES AND THEN THE OXYGENATOR SUDDENLY STOPPED. THEY TRIED TO REPLACE IT; HOWEVER, IT WAS TOO LATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THERE WERE NO OBVIOUS ANOMALIES, SUCH AS A BREAK, IN THE APPEARANCE. THE ACTUAL SAMPLE WAS RINSED, DRIED AND BUILT INTO A CIRCUIT WITH TUBES. BOVINE BLOOD (@HCT35% AND TEMP. 37OC) WAS CIRCULATED IN THE CIRCUIT, WHILE THE PRESSURE DROP WAS DETERMINED AT EACH FLOW RATE. THE OBTAINED VALUES WERE CONFIRMED TO MEET THE MANUFACTURING SPECIFICATIONS. THE CIRCUIT WAS FLUSHED WITH WATER. NO CLOT WAS FOUND INSIDE THE ACTUAL SAMPLE. THE PERFUSION RECORD FROM THE INVOLVED SURGERY AND THE ADDITIONAL INFORMATION WERE REVIEWED AS FOLLOWS: THE CIRCULATION STOPPED 90 MINUTES AFTER THE INITIATION OF THE CIRCULATION AND THE ACTUAL SAMPLE WAS CHANGED OUT AT 12:40. THIS INDICATES THAT THE ACTUAL SAMPLE WAS NOT OBSTRUCTED AT THE BEGINNING OF THE CIRCULATION. IT IS ASSUMABLE THAT THE ACTUAL SAMPLE BECAME OBSTRUCTED DURING THE CIRCULATION DUE TO SOME FACTOR(S), INCLUDING THE CLOT FORMATION. THE BLOOD FLOW RATE INDICATED IN THE PERFUSION RECORD IS ALWAYS 4.3L/MIN. FROM THIS, IT CANNOT BE KNOWN WHEN THE FLOW RATE DROPPED DRAMATICALLY. THE VALUE OF THE PRESSURE INSIDE THE CIRCUIT (LINE) INDICATED IN THE PERFUSION RECORD IS 110 - 139. FROM THIS, IT CANNOT BE KNOWN WHEN THE PRESSURE WAS INCREASED DRAMATICALLY. REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULTS VERIFIED THE RETURNED SAMPLE WAS OF THE NORMAL PRODUCT. IT IS LIKELY THAT DUE TO SOME FACTOR(S) EMERGED DURING THE CIRCULATION LED CLOTS TO FORM, RESULTING IN OBSTRUCTION IN THE ACTUAL SAMPLE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON MAY 2, 2019. THERE WAS A SUDDEN BLOCK OF THE MEMBRANE; THE CIRCULATON STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395352 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death