BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 15391309 · Received September 9, 2022

    Report

    Report Number
    9681834-2022-00174
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    August 11, 2022
    Report Date
    September 9, 2022
    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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED . AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. PATIENT SEX: REQUESTED, NOT PROVIDED. WEIGHT: REQUESTED, NOT PROVIDED . ETHNICITY: REQUESTED, NOT PROVIDED. RACE: REQUESTED, NOT PROVIDED. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION - CLINICAL ENGINEER. PMA/510(K): K130520. VISUAL INSPECTION OF THE ACTUAL SAMPLE DID NOT FIND ANY ANOMALY SUCH AS A BREAKAGE IN ITS APPEARANCE. AFTER THE SALINE SOLUTION WAS FLOWED INTO THE ACTUAL SAMPLE BY A HEAD, VISUAL INSPECTION OF THE GAS TRANSFER SECTION WAS PERFORMED. AS A RESULT, THE FORMATION OF BLOOD CLOT WAS FOUND. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY THE TIMING OF THE FORMATION OF THIS BLOOD CLOT (E.G., AT THE TIME OF USE, OR AT THE TIME OF RETURN). AFTER INVESTIGATION OF THE ACTUAL SAMPLE, THE SAMPLE WAS INSTALLED INTO A CIRCUIT CONSISTING OF TUBES, AND THE PRESSURE DROP WHEN CIRCULATING SALINE SOLUTION IN THE BLOOD CHANNEL AT EACH FLOW RATE WAS MEASURED. NO SIGNIFICANT DIFFERENCE WAS FOUND COMPARED TO THE CURRENT PRODUCT. AFTER FILLING THE SALINE SOLUTION CONTAINING GLUTARALDEHYDE SOLUTION IN THE ACTUAL SAMPLE AND FIXING THE BLOOD CLOT FOUND, THE HOUSING AND FILTER WERE REMOVED, AND VISUAL INSPECTION OF THE GAS TRANSFER SECTION WAS PERFORMED. NO BLOOD CLOT FORMATION LEADING TO INCREASED PRESSURE WAS FOUND. NO ANOMALY WAS FOUND IN THE WINDING STATE OF THE FIBER. AFTER INVESTIGATION, THE FIBER LAYER WAS REMOVED, AND VISUAL INSPECTION OF THE GAS TRANSFER SECTION WAS PERFORMED. NO BLOOD CLOT FORMATION LEADING TO INCREASED PRESSURE WAS FOUND. NO ANOMALY WAS FOUND IN THE WINDING STATE OF THE FIBER. THE OUTER CYLINDER WAS REMOVED FROM THE ACTUAL HEAT EXCHANGER, AND VISUAL AND MAGNIFYING INSPECTIONS OF THE HEAT EXCHANGER WAS PERFORMED. AS A RESULT, THE FORMATION OF BLOOD CLOT WAS FOUND ON THE BOTTOM SURFACE. NO ANOMALY SUCH AS A DEFORMATION OF OXYGENATOR THAT LED TO AN OBSTRUCTION WAS FOUND. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL FIBER FOUND THAT BLOOD CELL COMPONENTS SUCH AS WHITE BLOOD CELLS AND BLOOD PLATELETS HAD BEEN ADHERED. REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. BASED ON THE INVESTIGATION RESULT, THE PRESSURE DROP OF THE ACTUAL SAMPLE UPON RECEIPT WAS THE SAME AS THE CURRENT PRODUCT, AND NO OBSTRUCTION WAS FOUND. ALTHOUGH BLOOD CELL COMPONENTS SUCH AS BLOOD PLATELETS AND WHITE BLOOD CELLS ADHERED TO THE FIBER OF ACTUAL SAMPLE, NO BLOOD CLOT FORMATION LEADING TO AN INCREASE IN PRESSURE WAS FOUND. THEREFORE, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT IFU REFERENCE: "DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. (WARNINGS)" "ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. (WARNINGS)" TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE CAPIOX CUSTOM PACK INVOLVED WAS USED DURING EMERGENCY SURGERY FOR THROMBECTOMY. THE BLOOD REMOVAL CONDITION WAS NOT GOOD; HOWEVER, THE FLOW RATE WAS APPROXIMATELY 2L/MIN, AND THE PRE OXYGENATOR PRESSURE INCREASED (PRE OXYGENATOR PRESSURE: 450MMHG, AND POST OXYGENATOR PRESSURE: 150MMHG). PREPARATIONS WERE MADE TO REPLACE THE OXYGENATOR. WHEN PREPARATIONS FOR DEVICE REPLACEMENT WERE COMPLETE, FLOW RATE WAS 4.8L/MIN AND THE PRE OXYGENATOR PRESSURE WAS 250 MMHG, WHICH HAD FALLEN TO NORMAL LEVELS. THE OXYGENATOR WAS REPLACED. THERE ARE NO REPORTS OF PATIENT HARM. THE PRODUCT WAS REPLACED DURING BLOOD CIRCULATION. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED. THE EVENT OCCURRED INTRA-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359892 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 220407

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other