BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 17322540 · Received July 13, 2023

    Report

    Report Number
    9681834-2023-00136
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 13, 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 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 THE ACTUAL SAMPLE UPON RECEIPT WAS ONLY AN OXYGENATOR, AND NO RESERVOIR WAS RETURNED. 1: INVESTIGATION OF THE ACTUAL SAMPLE: 1.1. VISUAL INSPECTION OF THE ACTUAL SAMPLE · NO ANOMALY SUCH AS BREAKAGE WAS FOUND. 1.2. LEAK TEST OF THE ACTUAL SAMPLE · THE ACTUAL SAMPLE WAS INSTALLED INTO A CIRCUIT CONSISTING OF TUBES, AND SALINE SOLUTION WAS CIRCULATED. NO LEAKAGE OR AIR DRAWING WAS FOUND. · AFTER THE BLOOD CHANNEL WAS FILLED WITH SALINE SOLUTION, THE BLOOD OUTLET SIDE WAS CLAMPED, AND PRESSURE OF 2 KGF/CM2 WAS APPLIED FROM THE BLOOD INLET SIDE INTO THE BLOOD CHANNEL. NO LEAKAGE WAS FOUND. · WITH THE BLOOD CHANNEL FILLED WITH SALINE SOLUTION, THE WATER OUTLET SIDE WAS CLAMPED, AND PRESSURE OF 3 KGF/CM2 WAS APPLIED FROM THE WATER INLET SIDE INTO THE WATER CHANNEL. NO AIR FLOWED INTO THE BLOOD SIDE WAS FOUND. 2:RECORD REVIEW: 2.1. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE · NO ANOMALY WAS FOUND. 2.2. PAST COMPLAINT FILE · NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT# WAS FOUND. 2.3. MANUFACTURING DATE: MARCH 23, 2023 CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, NO ANOMALY THAT COULD LEAD TO LEAKAGE WAS FOUND IN THE RETURNED ACTUAL SAMPLE (OXYGENATOR). SINCE NO LEAKAGE WAS FOUND IN THE ACTUAL SAMPLE, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. 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).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT APPROXIMATELY AN HOUR AFTER PRIMING THE CPB CIRCUIT, THE LEVEL SENSOR SOUNDED, CONFIRMING THAT THE FLUID LEVEL HAD LOWERED. AT FIRST, THE LIQUID LEVEL WAS APPROXIMATELY 300ML ON THE SCALE LABEL OF THE RESERVOIR, BUT THE LEVEL SENSOR RANG WHEN IT WAS LESS THAN 250ML. THE VOLUME OF PRIMING LIQUID WAS IMMEDIATELY ADDED AND CHECKED IT, BUT THE LIQUID LEVEL IMMEDIATELY BECAME LOW. THEREFORE, THE CIRCUIT WAS REPLACED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698554 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 230323

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown