BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 14828303 · Received June 27, 2022

    Report

    Report Number
    9681834-2022-00102
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 27, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781758
    PMA / PMN Number
    K071572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. TELEPHONE NUMBER - REQUESTED, NOT PROVIDED. OCCUPATION - CHIEF PERFUSIONIST. PMA/510K # - K130280. 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. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. (B)(4).

    Additional Manufacturer Narrative · 0

    THE ACTUAL SAMPLE WAS NOT RETURNED TO ASHITAKA FACTORY, THEREFORE AN EVALUATION OF THE ACTUAL SAMPLE COULD NOT BE PERFORMED. THE PROVIDED PHOTOS AND VIDEO OF THE ACTUAL PRODUCT WERE CONFIRMED. ANY ANOMALY SUCH AS BREAKAGE THAT COULD LEAD TO GAS TRANSFER FAILURE COULD NOT BE READ FROM THE PHOTOS. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT CONFIRMED THAT THERE WAS NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES. BASED ON THE INVESTIGATION RESULT, ANY ANOMALY SUCH AS BREAKAGE THAT COULD LEAD TO GAS TRANSFER FAILURE COULD NOT BE READ FROM THE PROVIDED PHOTOS, AND ALSO NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD. IT WAS DESCRIBED IN THE REPORTED ISSUE THAT "THE PATIENT SMOOTHLY OFF AFTER DONE ECHO AND PROTAMINE GIVEN TO THE PATIENT. AFTER FEW MINUTES, PATIENT GOT SOME PROBLEM AGAIN WE GAVE THE HEPARIN AND INITIATE THE BYPASS THE PATIENT. SECOND TIME WE FOUND PROBLEM IN OXYGENATOR AND THE OXYGENATION NOT OCCUR". THEREFORE, IT WAS INFERRED THAT AFTER NEUTRALIZING HEPARIN WITH PROTAMINE, BLOOD CLOTS FORMED IN THE OXYGENATOR, LEADING TO GAS TRANSFER FAILURE. HOWEVER, SINCE THE ACTUAL PRODUCT COULD NOT BE CONFIRMED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. IFU STATES: "DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. (WARNINGS): ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. (WARNINGS)." 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 FIRST THEY DID BYPASS FOR 75 MIN. THEN THE PATIENT WAS SMOOTHLY OFF AFTER THE ECHO WAS DONE. PROTEMEN WAS GIVEN TO THE PATIENT AT THAT TIME OUT ALL PUMP SUCKERS WAS OFF. AFTER A FEW MINUTES, THE PATIENT HAD SOME PROBLEM AGAIN, SO THEY GAVE THEM HEPARIN AND INITIATED BYPASS THE PATIENT. SECOND TIME WE FOUND PROBLEM IN OXYGENATOR AND THE OXYGENATION DID NOT OCCUR AND THEY REPLACED WITH NEW ONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931573 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200817 04987350781758

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention