BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 17805387 · Received September 24, 2023

    Report

    Report Number
    9681834-2023-00181
    Event Type
    Malfunction
    Date Received
    September 24, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 24, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    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

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3: PATIENT SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: CLINICAL ENGINEER. G4: PMA/510(K): K130520. 1. INVESTIGATION OF THE ACTUAL SAMPLE: 1.1. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT NO ANOMALY SUCH AS A BREAKAGE WAS FOUND. 1.2. 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. NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. 1.3. THE FIBER LAYER WAS REMOVED GRADUALLY, AND VISUAL INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. NO FORMATION OF BLOOD CLOTS LEADING TO AN INCREASE IN PRESSURE WAS FOUND. NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. 1.4. THE OUTER CYLINDER WAS REMOVED FROM THE HEAT EXCHANGER, AND VISUAL AND MAGNIFYING INSPECTIONS OF THE HEAT EXCHANGER WERE PERFORMED. NO ANOMALY SUCH AS DEFORMATION THAT COULD LEAD TO AN OBSTRUCTION WAS FOUND IN THE HEAT EXCHANGER. 1.5. ELECTRON MICROSCOPIC INSPECTION OF THE FIBER BLOOD CELL COMPONENTS SUCH AS PLATELETS AND WHITE BLOOD CELLS WERE ADHERED. 2. RECORD REVIEW: 2.1. CONFIRMATION OF THE PUMP RECORD. IT WAS FOUND THAT THE PRESSURE DROP AFTER STARTING CARDIOPULMONARY BYPASS WAS 277 MMHG. IT WAS FOUND THAT ALTHOUGH THE FLOW RATE REMAINED AT 5.6 L/MIN, THE PRESSURE DROP DECREASED APPROX. 10 MINUTES AFTER THE START OF CIRCULATION, AND REMAINED AT APPROXIMATELY 130 MMHG UNTIL THE END OF CARDIOPULMONARY BYPASS. 2.2. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE NO ANOMALY WAS FOUND. 2.3. PAST COMPLAINT FILE. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT# WAS FOUND. 2.4. MANUFACTURING DATE: FEBRUARY 21, 2023. 3. CAUSE OF OCCURRENCE/CONCLUSION: AS A POSSIBLE CAUSE OF OCCURRENCE, IT WAS INFERRED THAT BLOOD WITH ACTIVATED PLATELET AND WHITE BLOOD CELL AGGREGATION ABILITY FLOWED INTO THE OXYGENATOR FOR SOME REASON, CAUSING IT TO OBSTRUCT. THIS CAUSED A TEMPORARY INCREASE IN PRESSURE. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THIS CASE FROM THE CONDITION OF ACTUAL SAMPLE. RELEVANT 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 AS SOON AS THE PUMP WAS TURNED ON, THE PRESSURE INCREASED. AFTER 10 MINUTES THE PRESSURE STARTED TO RETURN. IT HAS RETURNED TO NEAR NORMAL. THE PRODUCT WAS CONTINUED TO USE UNTIL THE END OF PROCEDURE. IMMEDIATELY AFTER THE PRESSURE WAS INCREASED, 2000 ML OF BICARBON-BASED REPLACEMENT FLUID WAS ADDED TO DILUTE THE SOLUTION. IT IS UNCLEAR WHETHER THIS WAS DUE TO DILUTION OR TIME, BUT THE CONDITION RETURNED TO NORMAL AND THE PROCEDURE WAS COMPLETED. HOWEVER, ALTHOUGH PROCEDURES USUALLY PERFORMS WITH FIO2 OF AROUND 60%, THIS TIME IT REMAINED RELATIVELY HIGH. IT WAS HOVERING BETWEEN 70% AND 80%. EXCEPT FOR THE PRESSURE INCREASE IMMEDIATELY AFTER THE PUMP WAS TURNED ON AND VALUE OF FIO2, EVERYTHING RETURNED TO NORMAL. THE PATIENT WAS NOT HARMED AND THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834196 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 230221

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown