BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX15

    MDR report key: 4192312 · Received October 22, 2014

    Report

    Report Number
    9681834-2014-00265
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 22, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER SERIOUS - THE REPORTED INFORMATION INDICATES THAT THE PATIENT MAY HAVE EXPERIENCED BLOOD LOSS DUE TO DEVICE CHANGE OUT. HOWEVER, IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT. (B)(4). THE ACTUAL DEVICE WAS RETURNED AND EVALUATED. VISUAL INSPECTION CONFIRMED THAT THERE WERE NO ANOMALIES IN APPEARANCE. THE DEVICE WAS PERFORMANCE TESTED BY BEING ATTACHED TO A CIRCUIT WITH TUBES AND 1L OF SALINE SOLUTION WAS CIRCULATED THROUGH THE DEVICE. THE PRESSURE DROP OF THE ACTUAL SAMPLE WAS FOUND TO BE HIGHER THAN THAT OF THE RETENTION SAMPLE PULLED FROM THE CURRENT PRODUCTION RUN. HOWEVER, THE OCCURRENCE OF THE PRESSURE DROP COULD NOT BE DETERMINED SINCE THE FLOW RATE DURING THE EVENT WAS 1.5~2.0L/MIN. THE PRESSURE DROP WAS DETERMINED AT THE FLOW RATE OF 1.5L/MIN AT THE MAXIMUM SO AS NOT TO DISTURB OR REMOVE ANY REMAINING BLOOD THROMBUS IN THE RETURNED DEVICE. FURTHER INVESTIGATION REVEALED THE ADHESION OF ERYTHROCYTE COMPONENTS, INCLUDING DEFORMED RED CELLS (ECHINOCYTE), BLOOD PLATELETS AND FIBRIN, ON THE FILTER, THE FIBER SURFACE AND ON THE INTERIOR OF THE HEAT EXCHANGER. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN PREVIOUSLY REPORTED. BASED UPON THE AVAILABLE INFORMATION, THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED. THERE ARE MANY COMPLEX CLINICAL VARIABLES THAT MAY HAVE AFFECTED THE REPORTEDLY OBSERVED CONDITIONS DURING THE PROCEDURE. HOWEVER, THERE IS NO INDICATION THAT THE REPORTED EVENT WAS RELATED TO A PRODUCT MALFUNCTION OR DEFECT. DEVICE LABELING ADDRESSES THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE CAUTION SECTION FOUND IN THE INSTRUCTIONS-FOR-USE WITH STATEMENTS SUCH AS, "DO NOT SUPPLY GAS DURING PRIMING." (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A CAPIOX FX15 WAS USED DURING A PROCEDURE THAT INCLUDED AVR + TAP + CABG. ABOUT 5 MINUTES AFTER EXTRACORPOREAL CIRCULATION WAS STARTED, THE BLOOD PRESSURE BEFORE THE OXYGENATOR WAS PLACED INCREASED TO MORE THAN 300MMHG. THE OXYGENATOR WAS REPLACED WITH A NON-TERUMO OXYGENATOR. IT WAS NOTED THAT THE INCIDENT OCCURRED BEFORE THE AORTIC CROSS CLAMPING, AND THE BLOOD FLOW RATE AT THE TIME WAS 1.5~2.0L/MIN. ALSO NOTED WAS THE COMPOSITION OF THE PRIMING SOLUTION WHICH CONTAINED 6% BORBEN, ACETATED RINGER'S INJECTION AND THE PATIENT'S WASHED RED BLOOD CELLS. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WAS NO HARM TO THE PATIENT AND IS REPORTED AS "DOING OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674110 CAPIOX FX15 BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 140326

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other