BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 11606912 · Received April 2, 2021

    Report

    Report Number
    9681834-2021-00043
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 2, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION-CLINICAL ENGINEER. PMA/510(K)- K130280. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. IFU STATES: DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX25 OXYGENATOR AND RESERVOIR. DO NOT USE THIS PRODUCT FOR A PERIOD IN EXCESS OF SIX HOURS. EXCESSIVE USE FOR OVER SIX HOURS MAY LEAD TO PLASMA LEAK AND THROMBI FORMATION, WHICH MAY COMPROMISE THE GAS EXCHANGE PERFORMANCE. IT IS LIKELY THAT IF THE BLOOD PROPERTY IS CHANGED FOR SOME REASON, A SURFACE-ACTIVE SUBSTANCE MAY BE GENERATED IN BLOOD, AND THIS MAY DISRUPT THE RELATION BETWEEN THE SURFACE TENSION OF BLOOD AND THE GAS PRESSURE, WHICH IS BALANCED IN THE MICROPORES OF THE FIBER. SUCH A CONDITION MAY LEAD TO PLASMA LEAK; INCREASING PRESSURE IN THE OXYGENATOR MODULE DUE TO SOME FACTORS, SUCH AS CLOTTING, MAY CAUSE THE PRESSURE APPLIED FROM THE BLOOD CHANNEL TO THE GAS CHANNEL TO GET INCREASED. THIS MAY INCREASE FORCE TO PUSH THE BLOOD CORPUSCLE COMPONENTS OUT INTO THE GAS CHANNEL, RESULTING IN A PLASMA LEAK. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THIS REPORT IS FOR THE FIRST DEVICE REPORTED, FOR THE SECOND DEVICE REPORTED THAT WAS USED ON THE SAME PATIENT SEE MDR 9681834-2021-00044. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED DURING A NORMAL AVR PROCEDURE. WHILE THE PROCEDURE WAS BEING PROLONGED DUE TO REPEATED CLAMPING/DECLAMPING, A PLASMA LEAK OCCURRED. THE FIRST OXYGENATOR WAS CHANGED OUT TO CONTINUE THE PROCEDURE. THOUGH THE PROCEDURE WAS COMPLETED, THE SECOND OXYGENATOR ALSO SHOWED A PLASMA LEAK ISSUE. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504259 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other