BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 8014059 · Received October 29, 2018

    Report

    Report Number
    9681834-2018-00194
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    October 10, 2018
    Report Date
    October 29, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K130520 THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT DID NOT FIND ANY OBVIOUS ANOMALY, SUCH AS A BREAK, IN THE APPEARANCE. THE ACTUAL SAMPLE, AFTER HAVING BEEN RINSED, WAS BUILT INTO A CIRCUIT WITH TUBES AND , WITH THE USE OF A CENTRIFUGAL PUMP, SALINE SOLUTION WAS CIRCULATED IN THE BLOOD PHASE. NO LEAK WAS OBSERVED. AFTER THE LEAK TEST, WITH THE BLOOD OUTLET PORT CLAMPED, THE BLOOD PHASE WAS PRESSURIZED BY APPLYING AN AIR OF 2.0KGF/CM2 (APPROX. 1471MMHG) TO IT FROM THE BLOOD INLET PORT. NO LEAK WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO FINDINGS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULTS, THE ACTUAL SAMPLE WAS VERIFIED TO BE THE NORMAL PRODUCT WITH ANOMALY WHICH WOULD RELATE TO THE REPORTED LEAK. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED. THE IFU STATES: "AFTER ALL AIR BUBBLES ARE ELIMINATED, CIRCULATE AT FULL FLOW FOR 10 MIN TO CHECK OXYGENATOR AND TUBING FOR LEAKAGE OR ANY OTHER PROBLEM." 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 LEAKAGE ON THE INVOLVED CAPIOX DEVICE IMMEDIATELY AFTER THE START OF CIRCULATION. A FEW DROPS OF BLOOD WERE NOTED RIGHT BENEATH THE THERMISTOR PROBE. THE ACTUAL SAMPLE WAS CHANGED OUT TO A NEW PRODUCT AND THE SURGERY WAS COMPLETED WITH IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FINAL PATIENT IMPACT IS UNKNOWN. BLOOD LOSS WAS REPORTED TO BE A FEW DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853136 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 180606

    Patients

    Seq Age Sex Outcome Treatment
    1 Other