BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 7613665 · Received June 19, 2018

    Report

    Report Number
    9681834-2018-00107
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 19, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350771094
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED 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. FOR THIS REASON, EVALUATION CODE 11 HAS BEEN REFERENCED IN THE CONCLUSIONS SECTION OF H6. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER REPORT OF THIS NATURE WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. 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.

    Additional Manufacturer Narrative · 0

    IT WAS INITIALLY REPORTED THAT THE ACTUAL DEVICE WAS AVAILABLE. IT HAS NOW BEEN REPORTED THAT THE ACTUAL DEVICE IS NO LONGER AVAILABLE. THEREFORE, THE INVESTIGATION IS BASED ON EVALUATION OF THE USER FACILITY INFORMATION AND A RETENTION SAMPLE FROM THE REPORTED PRODUCT CODE/LOT NUMBER COMBINATION. VISUAL INSPECTION REVEALED NO ANOMALIES, SUCH AS A BREAK, IN THE APPEARANCE. THE RETENTION SAMPLE WAS BUILT INTO A CIRCUIT. BOVINE BLOOD WAS CIRCULATED IN THE CIRCUIT, WHILE THE PRESSURE DROP WAS DETERMINED AT EACH FLOW RATE. THE OBTAINED VALUES WERE CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. NO OBSTRUCTION INSIDE THE OXYGENATOR MODULE WAS FOUND. AFTER THE ABOVE TEST, BOVINE BLOOD WAS KEPT CIRCULATED FOR SIX HOURS. NO OBSTRUCTION OCCURRED. WHEN THE CIRCULATION WAS CEASED, THE OXYGENATOR MODULE WAS FLUSHED WITH SALINE SOLUTION. NO CLOT WAS FOUND INSIDE THE OXYGENATOR MODULE. THE INVESTIGATION RESULT VERIFIED THAT THE RETENTION SAMPLE WAS THE NORMAL PRODUCT. AS A CAUSE OF THIS COMPLAINT, IT IS LIKELY DUE TO SOME FACTOR(S), CLOTS FORMED AND OBSTRUCTED THE ACTUAL SAMPLE. WITH THE ABSENCE OF THE ACTUAL SAMPLE TO EVALUATE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE IFU STATES: "DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM."

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A HIGH PRESSURE DROP IN THE ABSENCE OF GAS EXCHANGE ALTERATION ON THE INVOLVED CAPIOX DEVICE. ENTERED IN BYPASS WITH PATIENT IN VENTRICULAR FIBRILLATION, HEPARIN DONE DURING FV AND IT ADDED IN THE PRIME (10.000 U/I). AFTER 10 MINUTES ON BY PASS WITH A FLOW OF 4900 ML / MIN AND ACT HIGHER THAN 480 THERE WAS AN INCREASE OF OXY INLET PRESSURE (440 MMHG) AND A NORMAL OUTLET PRESSURE (70 MMHG) WITHOUT ALTERATION OF THE GASEOUS EXCHANGES (GAS BLENDER FIO2 AT 60% AND 2.5 L / M OF AIR). ALL THE MEASURES ENVISAGED TO DECREASE THE PRESSURE DROP (ADD OF ALBUMIN AND SODIUM NITROPRUSSIDE) DID NOT HAVE ANY RESULTS SO IT WAS DECIDED TO DECREASE THE TEMPERATURE AND REPLACE THE OXYGENATOR. BLOOD LOSS WAS REPORTED TO BE 400 ML. THE PROCEDURE OUTCOME IS UNKNOWN. FINLA PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458289 CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 170822 04987350771094

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention