BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25

    MDR report key: 11357330 · Received February 22, 2021

    Report

    Report Number
    9681834-2021-00015
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    February 4, 2021
    Report Date
    February 22, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION-CLINICAL ENGINEER. PMA/510(K)- K130520. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. 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 STATES: DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. IT IS LIKELY THAT BLOOD CLOTS WERE FORMED AND CLOGGED THE CR FILTER DUE TO BLOOD WITH ACTIVATED COAGULATION FACTORS FLOWED INTO THE RESERVOIR; BLOOD CLOTS AND TISSUE FRAGMENT SUCKED FROM THE SURGICAL FIELD FLOWED INTO THE RESERVOIR, RESULTING IN THE CLOGGING. 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. IT WAS A THORACIC AORTA CASE. IN LESS THAN 30 MINUTES FROM THE START OF CIRCULATION, THE CR FILTER OF THE RESERVOIR RR40V CLOGGED, THE PRESSURE AT THE CR PART INCREASED, AND SUCTION BECAME IMPOSSIBLE. ANOTHER RR40V WAS ADDED AND USED AS CR. IT WAS CONNECTED TO THE 3/8 PORT NEXT TO THE INLET PORT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256447 CAPIOX FX25 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 201110

    Patients

    Seq Age Sex Outcome Treatment
    1