BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 17278315 · Received July 7, 2023

    Report

    Report Number
    9681834-2023-00130
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 7, 2023
    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

    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. D4: UDI NO: 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: 510(K) NO: K071494, K130520. INSPECTION OF THE ACTUAL SAMPLE: 1.1. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT - THE CROSS SECTION OF FIBER INSIDE THE HOUSING WAS OBSERVED TO HAVE A REDDISH DISCOLORATION ON THE GAS CHANNEL SIDE. - NO ANOMALY SUCH AS A BREAKAGE WAS FOUND. 1.2. LEAK TEST OF THE ACTUAL SAMPLE (AFTER RINSING) - NO LEAKAGE WAS OBSERVED WHEN SALINE SOLUTION WAS CIRCULATED AT A FLOW RATE OF 7 L/MIN AND BACK PRESSURE OF 200 MMHG. 1.3. THE BLOOD CHANNEL WAS FILLED WITH SALINE SOLUTION, THE BLOOD OUTLET SIDE WAS BLOCKED, AND THEN BLOOD CHANNEL WAS PRESSURIZED AT 2KGF/CM2 FROM THE BLOOD INLET SIDE. NO LEAKAGE WAS OBSERVED. 1.4. THE ACTUAL SAMPLE WAS DISASSEMBLED FOR THE VISUAL INSPECTION OF THE INTERNAL CONDITION. - NO ANOMALY WAS OBSERVED IN THE STATE OF WOUND HOLLOW FIBER. - NO ANOMALY WAS OBSERVED IN THE HEAT EXCHANGER SUCH AS BLOCKAGE IN THE CHANNEL. 1.5. ELECTRON MICROSCOPIC INSPECTION OF EACH LAYER OF HOLLOW FIBER - IN COMPARISON WITH A CURRENT PRODUCT SAMPLE, NO ANOMALIES WERE OBSERVED IN THE OUTER SURFACE AND INNER SURFACE OF HOLLOW FIBER. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE/LOT#: 2.1. MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD - NO ANOMALY WAS FOUND. 2.2. PAST COMPLAINT FILE - NO OTHER SIMILAR REPORT WAS FOUND. 2.3. MANUFACTURING DATE: JANUARY 23, 2023. 3. CAUSE OF OCCURRENCE/CONCLUSION: FROM THE INVESTIGATION RESULT, AS NO LEAKAGE WAS OBSERVED ON THE ACTUAL SAMPLE DURING THE CIRCULATION TEST, THE LEAKAGE OF LIQUID AT THE TIME OF USE WAS CONSIDERED TO BE LEAKAGE OF PLASMA COMPONENT. AS A CAUSE OF THE PLASMA LEAKAGE, FROM OUR EXPERIENCE, THE FOLLOWING FACTOR WAS INFERRED. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF PLASMA LEAKAGE. - IT WAS CONSIDERED PROBABLE THAT SOME CHANGES IN BLOOD PROPERTIES CAUSED THE PRODUCTION OF SURFACTANT SUBSTANCES LEADING TO A BREAKDOWN OF THE RELATIONSHIP BETWEEN THE SURFACE TENSION OF BLOOD AND GAS RETAINED IN THE MICROPORES ON THE SURFACE OF THE FIBER, WHICH RESULTED IN A SUSCEPTIBILITY TO PLASMA LEAKAGE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX25 OXYGENATOR AND RESERVOIR. (B.PRIMING PROCEDURE 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). THIS REPORT IS FOR THE FIRST DEVICE REPORTED, FOR THE SECOND DEVICE REPORTED THAT WAS USED ON THE SAME PATIENT SEE MDR 9681834-2023-00131 AND FOR THE THIRD DEVICE REPORTED THAT WAS USED ON THE SAME PATIENT SEE MDR 9681834-2023-00132.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO CORRECT SECTION H2. IN THE INITIAL REPORT H2 WAS CHECKED FOR PRODUCT EVALUATION WHEN THAT SECTION SHOULD HAVE BEEN LEFT BLANK SINCE IT WAS THE INTIAL REPORT AND NOT A FOLLOW UP.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 2 TO CORRECT SECTION D3.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE CUSTOM PACK WAS USED FOR A THORACOABDOMINAL AORTIC REPLACEMENT. ABOUT FIVE HOURS INTO THE PROCEDURE, A BLOOD-LIKE FLUID WAS LEAKING AROUND GAS-OUT PORT. THE OXYGENATOR WAS REPLACED, AND CIRCULATION CONTINUED, HOWEVER TWO HOURS LATER A SIMILAR LEAK OCCURRED, THIS TIME FROM THE GAS-IN PORT, SO THE OXYGENATOR WAS REPLACED AGAIN. TWO HOURS LATER, ANOTHER LEAK OCCURRED, HOWEVER, THE CIRCULATION FINISHED WITH NO EXCHANGE OF OXYGENATOR. THE PRODUCT WAS CHANGED OUT TWICE IN TOTAL DURING THIS CASE. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014390 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 230123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention