BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 14349521 · Received May 10, 2022

    Report

    Report Number
    9681834-2022-00084
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 10, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO UDI AS THIS PRODUCT IS A BULK UNIT. 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 PROVIDED IMAGE FOUND THAT WHITE CLOT-LIKE DEPOSITS WERE OBSERVED IN THE OXYGENATION MODULE OF THE OXYGENATOR AFTER THE BLOOD INSIDE WAS DRAINED. FROM THE INVOLVED SERIAL NUMBER (B)(4), THE INVOLVED PRODUCT CODE AND LOT NUMBER WERE IDENTIFIED AS ZZ*FX05REA AND 210312 RESPECTIVELY. REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT /LOT# COMBINATION CONFIRMED THAT THERE WAS NO ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO SIMILAR COMPLAINT WITH THE INVOLVED PRODUCT /LOT# COMBINATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    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. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE AS RECEIVED FOUND NO BREAKAGE OR OTHER ANOMALIES IN THE APPEARANCE. THE ACTUAL SAMPLE AFTER CLEANED AND DRIED WAS BUILT INTO A CIRCUIT WITH TUBE, AND THEN BOVINE BLOOD (HCT 35% AND TEMP. 37°) WAS CIRCULATED IN THE CIRCUIT WHILE THE PRESSURE DROP WAS DETERMINED. THE OBTAINED VALUES WERE CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS. NO OCCLUSION IN THE FLOW PATH WAS CONFIRMED. AFTER THE ABOVE CIRCULATION TEST, NORMAL SALINE WAS FLOWED INTO THE BLOOD CHANNEL. AS A RESULT, NO FORMATION OF BLOOD CLOTS WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, NO ABNORMALITY WAS CONFIRMED IN THE ACTUAL SAMPLE DURING THE CIRCULATION TEST. THERE WAS NO ANOMALY IN THE MANUFACTURING RELATED RECORDS. AS A CAUSE OF THIS EVENT, IT WAS CONSIDERED POSSIBLE THAT BLOOD CLOTS MAY HAVE FORMED DUE TO SOME FACTOR (E.G., PATIENT BLOOD CHARACTERISTICS), BUT THE DEFINITE CAUSE COULD NOT BE CLARIFIED. REGARDING THE FORMATION OF BLOOD CLOTS, THE FOLLOWING WARNINGS CAN BE FOUND IN THE IFU (INSTRUCTIONS FOR USE) OF CAPIOX FX05: (I) DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. (II) ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED CONSIDERING PATIENT CONDITION AND PERFUSION TECHNIQUE TO PREVENT IT FROM CLOTTING IN THE SYSTEM.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AFTER BYPASS AND SURGERY WAS COMPLETED. THE CCP DRAINED THE OXYGENATOR AND NOTICED CLOTS HAD FORMED ON THE OUTSIDE OF THE FIBERS AND OUTSIDE OF THE FILTER MEMBRANE. NO, THE EVENT DID NOT RESULT IN DELAY IN BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. THE PROBLEM OCCURRED DURING CARDIOPULMONARY BYPASS. THE PRODUCT WAS NOT CHANGED OUT. THE ISSUE WAS NOT NOTICED UNTIL PATIENT WAS OFF BYPASS. THE PROCEDURE / SURGERY COMPLETED WAS SUCCESSFUL. THE PRODUCT MALFUNCTION CAUSE DID NOT CONTRIBUTE TO AN INJURY. THERE WAS NO BLOOD LOSS BECAUSE OF THE REPORTED ISSUE. THERE WERE NO PATIENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601659 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 210312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown