BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 7663201 · Received July 5, 2018

    Report

    Report Number
    9681834-2018-00115
    Event Type
    Malfunction
    Date Received
    July 5, 2018
    Date of Event
    June 12, 2018
    Report Date
    July 5, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K022115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K130493 THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ANOMALIES. THE ACTUAL DEVICE WAS BUILT INTO A CIRCUIT WITH TUBES. SALINE SOLUTION WAS FILLED AND CIRCULATED IN IT AND THE PRESSURE DROP WAS DETERMINED AT EACH FLOW RATE. AS THE RESULT, THE PRESSURE DROP WAS FOUND TO BE SLIGHTLY HIGHER THAN THAT OF THE CURRENT PRODUCT. NO ANOMALY WAS REVEALED. THE ACTUAL DEVICE WAS SUBJECTED TO ANOTHER UNAIDED VISUAL INSPECTION. ANY VISIBLE CLOT FORMATION WAS NOT FOUND. THE ACTUAL DEVICE WAS FIXED WITH GLUTARALDEHYDE SOLUTION AND THE HOUSING COMPONENT WAS REMOVED FOR FURTHER INSPECTION OF THE INSIDE OF THE OXYGENATOR MODULE. THE STATE OF THE FIBER WINDING WAS CONFIRMED TO BE NORMAL. SUBSEQUENTLY, THE FIBER LAYER WAS REMOVED FROM THE WINDING IN INCREMENTS OF 2MM AND EACH LAYER WAS SUBJECTED TO VISUAL INSPECTION. THERE WAS NO CLOT FORMATION THAT WAS VISIBLE WITH THE NAKED EYE ON THE FIBER WINDING. THE OUTER CYLINDER WAS REMOVED FROM THE HEAT EXCHANGER MODULE AND THE INSIDE OF THE HEAT EXCHANGER MODULE WAS SUBJECTED TO VISUAL AND MAGNIFYING INSPECTIONS. WHITE THROMBUS WAS FOUND TO HAVE FORMED. THE FIBER LAYERS REMOVED DURING THE TEST WERE INSPECTED UNDER MAGNIFICATION. NO CLOT FORMATION WAS OBSERVED. ELECTRON MICROSCOPIC INSPECTION OF THE FIBER ON EACH LAYER ON THE UPPER SIDE OF THE FIBER WINDING OBTAINED REVEALED NO FORMATION OF CLOTS THAT COULD BE A TRIGGER OF THE REPORTED PRESSURE VALUES WHICH WERE HIGHER THAN USUAL. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE REPORTED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO FINDINGS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE PRESSURE DROP TEST RESULT FOR THE ACTUAL DEVICE WAS CONFIRMED TO BE NORMAL. DURING THE INSPECTION OF THE ACTUAL DEVICE, WHITE THROMBUS WAS FOUND TO HAVE FORMED ON THE HEAT EXCHANGER MODULE. WITH THE CAUSE-AND-EFFECT RELATIONSHIP BETWEEN THE FORMATION OF THE WHITE THROMBUS AND THE REPORTED PRESSURE RISE NOT KNOWN. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED AT THE BEGINNING OF THE CIRCULATION, THE CAPIOX DEVICE PRESSURE WAS A LITTLE HIGHER THAN USUAL. WHEN THE FULL-FLOW STARTED, THE PRESSURE BECAME MUCH HIGHER. THE CIRCULATION WAS CONTINUED WITH PRESSURE RELEASE. THE PROCEDURE WAS COMPLETED WITH NO CHANGE OUT OF THE ACTUAL DEVICE. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505743 CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 180205

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR