BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 7409372 · Received April 9, 2018

    Report

    Report Number
    9681834-2018-00047
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 20, 2018
    Report Date
    April 9, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701183
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G.5 - 510(K): K130520 THE ACTUAL DEVICE HAS 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. 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

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION. THE ACTUAL DEVICE WAS RETURNED; THEREFORE, CONCOMITANT MEDICAL PRODUCTS HAS BEEN UPDATED. ADDITIONAL INFORMATION WAS RECEIVED AND HAS BEEN PROVIDED IN EVENT OF THE INITIAL REPORT, IT WAS STATED THAT DEVICE MANUFACTURER DATE WAS UNKNOWN DUE TO THE UNKNOWN LOT NUMBER, HOWEVER, THAT LOT NUMBER WAS PROVIDED AND THE DEVICE MANUFACTURE DATE WAS PROVIDED IN THE INITIAL REPORT. THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ANOMALIES. THE ACTUAL SAMPLE WAS RINSED, DRIED AND SUBJECTED TO ANOTHER VISUAL INSPECTION, AND NO ANOMALIES WERE FOUND. THE ACTUAL SAMPLE WAS BUILT INTO A CIRCUIT. BOVINE BLOOD (@HCT35% AND TEMP. 37OC) WAS CIRCULATED IN THE CIRCUIT, WHILE THE PRESSURE DROP WAS DETERMINED AT EACH FLOW RATE. THE OBTAINED VALUES WERE CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS. NO OBSTRUCTION WAS CONFIRMED. AFTER THE TEST, BOVINE BLOOD WAS KEPT CIRCULATED FOR 6 HOURS. NO OBSTRUCTION OCCURRED. WHEN THE CIRCULATION WAS CEASED, THE ACTUAL SAMPLE WAS FLUSHED WITH WATER. NO CLOT WAS FOUND INSIDE THE ACTUAL SAMPLE. 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. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULT VERIFIED THAT THE ACTUAL SAMPLE AFTER HAVING BEEN RINSED WAS THE NORMAL PRODUCT PRESENTING NO ISSUE RELATING TO AN OBSTRUCTION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED DURING AN AORTIC VALVE SURGERY: WHILE BEING ON BYPASS, THE DELTA PRESSURE INCREASED FROM 60 MMHG TO 250 MMHG. THE FIRST PART OF THE SURGERY WAS TERMINATED WITH THE SAME INVOLVED OXYGENATOR. AFTER TERMINATING THE BYPASS AND SURGERY, THE SURGEON DETECTED ANOTHER PROBLEM WITH THE PATIENT'S HEART AND DECIDED TO GO AGAIN ON BYPASS. THEY CHANGED THE OXYGENATOR BEFORE THEY STARTED AGAIN. THERE WAS NO ADVERSE IMPACT FOR THE PATIENT BECAUSE OF THE OXYGENATOR. THE PROCEDURE OUTCOME AND PATIENT'S CONDITION WAS REPORTED TO BE UNKNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO BLOOD LOSS, AND THERE WAS NO DELAY IN THE PROCEDURE. PATIENT WAS NOT TREATED AS INTENDED, HOWEVER, THIS WAS NOT BECAUSE OF THE OXYGENATOR. THE USER FACILITY ADDED A PROCEDURE BECAUSE THEY DETECTED SOMETHING ELSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252691 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 170630 04987350701183

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention