BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 18614080 · Received January 31, 2024

    Report

    Report Number
    9681834-2024-00007
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 10, 2024
    Report Date
    January 31, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DTZ
    UDI-DI
    04987350763471
    PMA / PMN Number
    K022115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K): K130493. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT FOUND NO ANOMALY. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D9, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. VISUAL AND MAGNIFYING INSPECTIONS OF THE ACTUAL SAMPLE FOUND THAT THE BLOOD INLET PORT HAD BEEN DEFORMED. NO ANOMALY SUCH AS DAMAGE WAS FOUND IN OTHER SECTIONS. LEAK TEST OF THE ACTUAL SAMPLE: THE ACTUAL SAMPLE WAS INSTALLED INTO A CIRCUIT CONSISTING OF TUBES, AND THE COLORED SALINE SOLUTION WAS CIRCULATED THROUGH THE ACTUAL SAMPLE AT A FLOW RATE OF 1.5 L/MIN. NO LEAKAGE WAS FOUND. THE BLOOD CHANNEL OF ACTUAL SAMPLE WAS FILLED WITH COLORED 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. THE WATER CHANNEL WAS FILLED WITH COLORED WATER, THE WATER OUTLET SIDE WAS CLAMPED, AND PRESSURE OF 3 KGF/CM2 WAS APPLIED FROM THE WATER INLET SIDE INTO THE WATER CHANNEL. NO LEAKAGE WAS FOUND. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND. BASED ON THE INVESTIGATION RESULT, NO LEAKAGE WAS FOUND IN THE ACTUAL SAMPLE. IN ASHITAKA FACTORY, 100% LEAK TEST, AND 100% VISUAL INSPECTION AT THE TIME OF ATTACHING A CAP TO THE PORT ARE PERFORMED. THEREFORE, IT WAS NOT POSSIBLE TO DETERMINE WHEN THE DEFORMATION OCCURRED AT THE BLOOD INLET PORT FROM THE CONDITION OF ACTUAL SAMPLE, AND IT WAS NOT POSSIBLE TO CLARIFY THE CAUSAL RELATIONSHIP WITH THE LEAKAGE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX RX05 OXYGENATOR AND RESERVOIR." "BAND ALL CONNECTIONS IN THE CIRCUIT."

    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 E2: HEALTH PROFESSIONAL: UNKNOWN E3: OCCUPATION: OTHERS G4: PMA/510(K): K130280 THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT FOUND NO ANOMALY. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND. 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 LEAKAGE WAS NOTICED BY THE PERFUSIONIST WHEN THEY STARTED THE PRIMING OF THE OXYGENATOR BEFORE THE START OF SURGERY. THE CAPIOX WAS REPLACED WITH A FRESH AND THE SURGERY WAS NOT INTERRUPTED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED. THE EVENT OCCURRED PRE-TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245785 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 230303 04987350763471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown