BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX05

    MDR report key: 9980534 · Received April 21, 2020

    Report

    Report Number
    9681834-2020-00064
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    March 31, 2020
    Report Date
    April 21, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. IT WAS CONFIRMED THAT THE ACTUAL SAMPLE WAS NO LONGER AVAILABLE FOR EVALUATION; THEREFORE, SECTION D10 HAS BEEN UPDATED. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. IFU STATES: DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. DO NOT USE AN OXYGENATOR THAT LEAKS. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): 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. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO FINDINGS. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX FX05 DEVICE WAS USED PRE-TREATMENT. THERE WAS A LEAK NEAR THE RESERVOIR OUTLET, FILTERS AT THE OUTLET OF THE VENOUS RESERVOIR. THE HOUSING WAS CRACKED AND LEAKED. THE EVENT OCCURRED PRIMING, AND THE PATIENT WAS NOT INVOLVED DURING THE INCIDENT AND WAS NOT HARMED. THE PRODUCT WAS CHANGED OUT. THERE WAS NO BLOOD LOSS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445905 CAPIOX FX05 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 190909 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA