BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 19029756 · Received April 2, 2024

    Report

    Report Number
    9681834-2024-00045
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 2, 2024
    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: DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3B: GENDER: N/A. A4: WEIGHT: 8.75 KILOGRAMS. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: CLINICAL ENGINEER. G4: PMA/510(K): K130280. 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. FORMATION OF BLOOD CLOTS 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. FORMATION OF BLOOD CLOTS WAS FOUND ON THE ENTIRE OF THE HEAT EXCHANGER. 1.5 ELECTRON MICROSCOPIC INSPECTION OF THE FIBER WAS PERFORMED. IT WAS FOUND THAT BLOOD CELL COMPONENTS SUCH AS PLATELETS AND RED BLOOD CELLS HAD BEEN ADHERED TO THE FIBER. 2. RECORD REVIEW: 2.1 CONFIRMATION OF THE PUMP RECORD. IT WAS FOUND THAT AFTER THE START OF EXTRACORPOREAL CIRCULATION, THE PRE OXYGENATOR PRESSURE GRADUALLY INCREASED IN RESPONSE TO CHANGES IN FLOW RATE, AND THE PRE OXYGENATOR PRESSURE INCREASED TO 350MMHG. THE TEMPERATURE CHANGE AFTER THE START OF EXTRACORPOREAL CIRCULATION WAS CONFIRMED. AS A RESULT, NO DECREASE IN TEMPERATURE WAS FOUND. THEREFORE, IT WAS INFERRED THAT COLD AGGLUTINATION CAUSED IT TO BECOME OBSTRUCTED. 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: APRIL 6, 2023. 3. CAUSE OF OCCURRENCE CONCLUSION: AS A POSSIBLE CAUSE OF OCCURRENCE, IT WAS LIKELY THAT DUE TO SOME FACTOR, BLOOD CLOTS FORMED AND BECAME OBSTRUCTED, RESULTING IN AN INCREASE IN PRESSURE DROP. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF BLOOD CLOTS FORMATION FROM THE INVESTIGATION RESULT OF ACTUAL SAMPLE. RELEVANT INSTRUCTIONS 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 IMMEDIATELY AFTER STARTING EXTRACORPOREAL CIRCULATION, THE DIFFERENCE BETWEEN THE PRE OXYGENATOR PRESSURE AND THE POST OXYGENATOR PRESSURE WAS BIG. EVEN WHEN THE NUMBER OF BLOOD OUTLET TUBES WAS CHANGED FROM ONE TO TWO, THE PRESSURE INCREASE WAS LARGE, SO THE FLOW RATE COULD NOT BE INCREASED TO 100% AND REMAINED AT 60% OF THE TARGET. ALTHOUGH THE ROTATION SPEED WAS INCREASED TO INCREASE THE FLOW RATE, THE OXYGENATOR INLET PRESSURE INCREASED FURTHER AND EXCEEDED 350 MMHG. ALTHOUGH WE CHECKED TO SEE IF THERE WAS ANY ANOMALY IN THE CIRCUIT, AND ALSO CHECKED THE CONDITION OF CANNULA, THERE WAS NO PROBLEM. ACT WAS 498 BEFORE STARTING (BOTTOM OF CHART) AND OVER 1000 DURING EXTRACORPOREAL CIRCULATION. AN ATTEMPT WAS MADE TO USE THE SINGLE OXYGENATOR OF THE OXYGENATOR PART FX05, BUT THE PRODUCT WITH THE REPLACEMENT CIRCUIT SPECIFICATIONS HAD NOT YET ARRIVED AT THE HOSPITAL (THE OLD LOT WAS IN STOCK). WE GAVE UP ON USING THE OXYGENATOR ALONE AND, ASSUMING THAT THE OXYGENATOR WAS OBSTRUCTED WITH BLOOD CLOTS, WE CONSIDERED REPLACING IT WITH THE FX15 CIRCUIT, WHICH HAS A LARGER MEMBRANE AREA, AND ATTEMPTED TO USE IT. HOWEVER, SINCE THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED, THE SURGERY WAS CANCELED AND WEANING WAS PERFORMED. AFTER STARTING EXTRACORPOREAL CIRCULATION, THE PLATELET COUNT DROPPED TO 120,000. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822157 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 230406

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Female