BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 12056324 · Received June 24, 2021

    Report

    Report Number
    9681834-2021-00114
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 24, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K130280. THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR THE INVESTIGATION. THE IMAGE PROVIDED OF THE ACTUAL PRODUCT SHOWED A FORMATION OF GLUE-LIKE CLOTS. THE BLOOD LEVEL WAS CONSIDERED TO HAVE BEEN AT LEAST 400 ML OR MORE BASED ON THE WET STATE OF THE DEFOAMER OF VENOUS FILTER. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU SATES: ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. THE RESERVOIR OF THIS PRODUCT IS DESIGNED TO STABILIZE THE BLOOD STORAGE SURFACE TO MAKE IT EASIER TO MANAGE, ON THE OTHER HAND, BLOOD IS DIFFICULT TO BE AGITATED IN THE RESERVOIR. BASED ON THIS CHARACTERISTIC AND EXPERIENCE, IT WAS LIKELY THAT BLOOD WITH ACTIVATED COAGULATION FACTORS FLOWED INTO THE RESERVOIR AND STAYED ON THE SURFACE, LEADING TO THE FORMATION OF BLOOD CLOTS, AND AFTERWARD, WHEN THE FLUID LEVEL WAS LOWERED, THE FORMATION OF CLOTS WAS REVEALED. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE AND THERE WAS BLOOD CLOTTING. THE PRODUCT WAS CHECKED, NO ABNORMITY WAS FOUND. THE OPERATOR FOUND BLOOD COAGULATION IN THE RESERVOIR AFTER TEN MINS OF CPB. ACT WAS OVER 500S BEFORE CPB START. THE PRODUCT WAS EXCHANGED A NEW ONE. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953729 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200604C 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other