BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 16698980 · Received April 7, 2023

    Report

    Report Number
    9681834-2023-00070
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    March 9, 2023
    Report Date
    April 7, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: REQUESTED, NOT PROVIDED. EXPLANTED DATE: REQUESTED, NOT PROVIDED. INITIAL REPORTER NAME AND ADDRESS: TELEPHONE NUMBER: UNKNOWN. INITIAL REPORTER OCCUPATION: PERFUSIONIST. 510K: K130520. REVIEW OF THE MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY IN THEM. REVIEW OF THE PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE/LOT FOUND NO OTHER SIMILAR CASE. THE ACTUAL DEVICE HAS NOT BEEN RECEIVED YET FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO: 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO: 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D9, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. INSPECTION OF THE ACTUAL SAMPLE: VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT FOUND THAT THE GAS-IN SIDE OF HOUSING AND THE ONE-WAY VALVE WERE DAMAGED. PHYSIOLOGICAL SALINE WAS FLOWED INTO THE ACTUAL SAMPLE BY A DIFFERENCE IN HEIGHT. AS A RESULT, LEAKAGE TO THE GAS-IN SIDE WAS OBSERVED. AS THIS SUGGESTED THAT THE INSIDE OF THE OXYGENATOR WAS ALSO DAMAGED, THE GAS EXCHANGE PERFORMANCE TEST COULD NOT BE PERFORMED. RECORD REVIEW: THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE SHOWED NO ANOMALY. PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE/LOT# SHOWED NO OTHER SIMILAR REPORT. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD OF THE ACTUAL SAMPLE. AS FOR THE CAUSE OF THIS INCIDENT, IT WAS NOT POSSIBLE TO CLARIFY IT BECAUSE THE CIRCULATION CONDITIONS WERE UNKNOWN. IFU STATES: "- START GAS SUPPLY WITH V/Q=1, AND FIO2=100%, THEN MAKE ADJUSTMENTS BASED ON BLOOD GAS MEASUREMENTS. - MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS AS FOLLOWS. A.CONTROL PAO2 BY CHANGING CONCENTRATION OF OXYGEN IN VENTILATING GAS USING GAS BLENDER. - TO DECREASE PAO2, DECREASE FIO2. - TO INCREASE PAO2, INCREASE FIO2. B.CONTROL PACO2 BY CHANGING THE TOTAL GAS FLOW. - TO DECREASE PACO2, INCREASE TOTAL GAS FLOW. - TO INCREASE PACO2, DECREASE TOTAL GAS FLOW. - UPON PATIENT REWARMING, ADJUST O2 CONCENTRATION, GAS FLOW RATE AND BLOOD FLOW RATE BY INCREASING THEM AS NEEDED BASED ON AN INCREASING IN PATIENTS METABOLISM. FAILURE TO ADJUST THE GAS SUPPLY AND THE BLOOD FLOW RATE APPROPRIATELY MAY CAUSE INSUFFICIENT O2 SUPPLY NEEDED OT THE AMOUNT OF THE PATIENT'S GASEOUS METABOLISM. - A PHENOMENON CALLED WET LUNG MAY OCCUR WHEN WATER CONDENSATION OCCURS INSIDE FIBERS OF MICROPOROUS MEMBRANE OXYGENATORS WITH BLOOD FLOWING EXTERIOR TO THE FIBERS. THIS MAY OCCUR WHEN OXYGENATORS ARE USED FOR A LONGER PERIOD OF TIME. IF WATER CONDENSATION AND/OR A DECREASE IN PAO2 AND/OR AN INCREASE IN PACO2 IS NOTED DURING EXTENDED OXYGENATOR USE, BRIEFLY INCREASING THE GAS FLOW RATE MAY IMPROVE THE PERFORMANCE. INCREASE GAS FLOW RATE, TO 20 L/MIN FOR 10 SECONDS. DO NOT REPEAT THIS FLUSHING TECHNIQUE, EVEN IF OXYGENATOR PERFORMANCE IS NOT IMPROVED." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT IN THE VERY BEGINNING, THEY NOTICED THAT THE PO2 WAS JUST 58, THE OXYGENATOR NUMBER#: 42044. THEN THEY CHANGED THE OXYGENATOR WITH NUMBER#: 438459 AND THE PO2 WAS 258. THE PROBLEM OCCURRED ONCE THE PROCEDURE STARTED, PATIENT WAS NOT INJURED, PERFUSIONIST CHANGED THE OXYGENATOR AND THE PROBLEM WAS SOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441140 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 220720 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention CUSTOM-MADE TUBING SET (BICAKCILAR)