BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 20493307 · Received October 21, 2024

    Report

    Report Number
    9681834-2024-00183
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 21, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: CLINICAL ENGINEER. G4: PMA/510(K): K130520. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT FOUND NO ANOMALY SUCH AS A BREAKAGE. THE ACTUAL SAMPLE WAS FILLED WITH GLUTARALDEHYDE-CONTAINING SALINE SOLUTION AND FIXED, THE HOUSING AND FILTER WERE REMOVED, AND VISUAL INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. THERE WAS NO ANOMALY IN THE CONDITION OF FIBER WINDING. THE FIBER LAYER WAS REMOVED GRADUALLY, AND VISUAL INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. IT WAS CONFIRMED THAT WHITE CLOTS HAD BEEN FORMED. NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. THE HEAT EXCHANGER WAS REMOVED FROM THE OUTER CYLINDER AND SUBJECTED TO VISUAL AND MAGNIFYING INSPECTION. THERE WAS NO ANOMALY LEADING TO CLOGGING. ELECTRON MICROSCOPIC INSPECTION OF THE FILTER AND THE FIBER REVEALED ADHESION OF BLOOD CELL COMPONENTS SUCH AS PLATELETS. AFTER THE INITIATION OF EXTRACORPOREAL CIRCULATION, THE PRESSURE AT THE INLET OF THE OXYGENATOR INCREASED IN RESPONSE TO CHANGES IN FLOW RATE, WITH A MAXIMUM READING OF 477MMHG (PRESSURE DROP: 274MMHG). THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. NO OTHER SIMILAR REPORT WAS FOUND. BASED ON THE INVESTIGATION, IT WAS INFERRED THAT THE INCIDENT OCCURRED DUE TO THE ACTUAL OXYGENATOR BEING CLOGGED WITH BLOOD CONTAINING AGGREGATION-ACTIVATED PLATELETS FOR AN UNKNOWN REASON. HOWEVER, THE SPECIFIC FACTOR RESPONSIBLE FOR THE PLATELET AGGREGATION COULD NOT BE DETERMINED FROM THE INVESTIGATION OF THE ACTUAL SAMPLE. RELEVANT INSTRUCTION FOR USE (IFU) REFERENCE: "DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR." "ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE AGGREGATION WAS SUSPECTED AT THE RESERVOIR DEFOAMING AREA FROM THE START OF SUCTION. PLATELET COUNT DECREASED. ARGATROBAN WAS ADMINISTERED, AND THE RESERVOIR AND THE OXYGENATOR WERE EXCHANGED; HOWEVER, THERE WAS NO IMPROVEMENT, AND THE CHEST WAS CLOSED. NO ADVERSE EVENT WAS REPORTED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219537 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-FX25W 240607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other