BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 15921016 · Received December 5, 2022

    Report

    Report Number
    9681834-2022-00241
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    October 26, 2022
    Report Date
    December 5, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT ETHNICITY: REQUESTED, NOT PROVIDED. PATIENT RACE: REQUESTED, NOT PROVIDED . IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. INITIAL REPORTER HEALTH PROFESSIONAL: REQUESTED, UNKNOWN. INITIAL REPORTER OCCUPATION: VIGILANCE RESPONSIBLE. PMA/510(K): K071572, 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. REVIEW OF THE MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO SIMILAR INDICATIONS REGARDING THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. 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).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D9, TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT REVEALED THAT NO ANOMALY SUCH AS A BRAKEAGE WAS FOUND. AFTER RINSING AND DRYING THE ACTUAL SAMPLE, THE OXYGENATOR WAS INSTALLED INTO A CIRCUIT CONSISTING OF TUBES, AND BOVINE BLOOD (HCT: 35%, TEMP.: 37°C) WAS CIRCULATED WITH A FLOW RATE OF 1.5 L/MIN. THEN, THE PRESSURE DROP WAS MEASURED. IT WAS CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS AND NO OBSTRUCTION WAS FOUND. AFTER CIRCULATION OF BOVINE BLOOD, SALINE SOLUTION WAS FLOWED IN THE BLOOD CHANNEL. NO BLOOD CLOT THAT LED TO THE OBSTRUCTION WAS FORMED. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE CONFIRMED THAT THERE WAS NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE ACTUAL SAMPLE AFTER RINSING. AS A CAUSE OF OCCURRENCE, IT WAS LIKELY THAT BLOOD-DERIVED OBSTRUCTION OCCURRED FOR SOME REASON. HOWEVER, SINCE NO ANOMALY WAS FOUND IN THE PERFORMANCE TEST OF ACTUAL SAMPLE, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THIS COMPLAINT FROM THE INVESTIGATION RESULT. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: THE END OF THE REPORT DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. (WARNINGS) ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. (WARNINGS)

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WHEN THE CAIPOX DEVICE OXYGENATION, WAS HIGH PRESSURED. OVERPRESSURE OF THE OXYGENATOR WAS HYPOTHESIZED WITH A POSSIBLE BREAKAGE OF OXYGENATING FIBER THAT HAS DETERMINED GASEOUS EMBOLISM ALONG THE ARTERIAL LINE OF THE CEC CIRCUIT. THERE WERE NO CONSEQUENCES AND WAS A REGULAR POST OPERATIVE COURSE. THE PROBLEM OCCURRED DURING A CARDIO BYPASS BEFORE X-CLAMPS. THE EVENT RESULTED IN A 20-MINUTE DELAY. THE PRODUCT WAS CHANGED OUT, CAPIOX FX05.NO CONSEQUENCES FOR THE PATIENT. AS A RESULT OF THE REPORTED ISSUE 380ML OF BLOOD WAS LOST. FLOW WAS 650ML/MINUTES AND PRESSURE OUT WERE 600MMHG. THE EVENT OCCURRED INTRA-OPERATIVE. THE DEVICE MALFUNCTION DUE TO INCREASING PRESSURE. THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY. THE FINAL PATIENT IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946104 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 211220 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female Required Intervention