BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 8458989 · Received March 28, 2019

    Report

    Report Number
    9681834-2019-00043
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    March 9, 2019
    Report Date
    March 28, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350763471
    PMA / PMN Number
    K022115
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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): K122590 THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED ON USER FACILITY INFORMATION AND EVALUATION OF THE RETENTION SAMPLE FROM THE INVOLVED PRODUCT CODE/LOT# COMBINATION. VISUAL INSPECTION REVEALED THERE WERE NO ANOMALIES, SUCH AS A BREAK, IN THE APPEARANCE. THE SAMPLE WAS TESTED FOR ITS GAS TRANSFER PERFORMANCE IN ACCORDANCE WITH THE MANUFACTURER SHIPPING INSPECTION PROTOCOL. BOVINE BLOOD ARRANGED TO HB12.0 G/DL, TEMPERATURE 37OC., PH:7.4, SVO2:65% AND PVCO2:45MMHG WAS CIRCULATED IN THE OXYGENATOR MODULE UNDER THE FOLLOWING CONDITIONS: @ V/Q=1, FIO2=100% AND THE FLOW RATE OF 2L/MIN. AND 1/MIN. THE FOLLOWING RESULTS WERE FOUND: O2 TRANSFER: @2L/MIN.= 118ML/MIN. @1L/MIN.= 68ML/MIN. CO2 REMOVAL: @2L/MIN.= 97ML/MIN. @1L/MIN.= 57ML/MIN. NO ANOMALIES WERE REVEALED IN THE GAS TRANSFER PERFORMANCE OF THE RETENTION SAMPLE, WITH THE OBTAINED VALUES MEETING THE MANUFACTURER SPECIFICATIONS. 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. IFU STATES: MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS AS FOLLOWS. CONTROL PAO2 BY CHANGING CONCENTRATION OF OXYGEN IN VENTILATING GAS USING GAS BLENDER. TO DECREASE PAO2, DECREASE FIO2. TO INCREASE PAO2, INCREASE FIO2. THIS INVESTIGATION RESULTS VERIFIED THE RETENTION SAMPLE WAS OF THE NORMAL PRODUCT. HOWEVER, WITH NO DEVICE RETURN 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 THAT THE PERFUSIONIST CHANGED OUT THE CAPIOX OXYGENATOR; AFTER INITIATING THE BYPASS INITIAL PO2 WAS 250, AND AFTER THIRTY MINUTES PO2 DROPPED DOWN TO 45 MMHG. THE PROCEDURE OUTCOME AND PATIENT OUTCOME WAS UNKNOWN. BLOOD LOSS WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252080 CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 180912 04987350763471

    Patients

    Seq Age Sex Outcome Treatment
    1 Other