BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX05

    MDR report key: 10194526 · Received June 25, 2020

    Report

    Report Number
    9681834-2020-00109
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    May 29, 2020
    Report Date
    June 25, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, EXPLANTED DATE: DEVICE WAS NOT EXPLANTED, 510(K) - K130280. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. VISUAL INSPECTION OF A CURRENT PRODUCT SAMPLE CONFIRMED THAT THERE WERE NO MOLDING-RELATED PROBLEMS, SUCH AS DEFORMITY, IN THE RESERVOIR OUTLET PORT OR IN THE 3/16" ADAPTER. REGARDING DIES FOR MOLDING THE RESERVOIR OUTLET PORT AND 3/16" ADAPTER, IT WAS CONFIRMED THAT NO CHANGES WERE MADE TO THE DIES FOR THE LAST ONE YEAR FROM THE DATE THE INVOLVED LOT WAS MANUFACTURED. NO ANOMALY WAS OBSERVED IN THE DAILY CLEANLINESS RECORD AND MAINTENANCE/INSPECTION RECORDS. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE JUDGEMENT CONTROL RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO FINDINGS. 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 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 THAT THE INVOLVED CAPIOX DEVICE WAS USED PRE-TREATMENT. THE PERFUSIONIST STATED THAT THEY HAD A LEAK FROM THE 3/16" ADAPTOR ON THE OUTLET OF A FX05 RESERVOIR. THEY FOUND IT DURING PRIMING. THERE WAS NO PATIENT INVOLVED AND OPERATION WENT AHEAD AS USUAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE FINAL PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 02JUN2020. THE EVENT DID NOT SIGNIFICANTLY DELAY THE PROCEDURE. A DIFFERENT TERUMO OXYGENATOR WAS USED WITH THE SAME PRODUCT CODE. FOLLOWING THE EVENT, THE PATIENT WAS TREATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659858 CAPIOX FX05 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 191224 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1