BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 GAS BLENDER SYSTEM

    MDR report key: 13168133 · Received January 5, 2022

    Report

    Report Number
    9611109-2022-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 8, 2021
    Report Date
    January 5, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DTX
    PMA / PMN Number
    K101046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO KNOWN PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE GAS BLENDER. THE INCIDENT OCCURRED IN USA A LIVANOVA SERVICE TECHNICIAN PERFORMED THE PMG AND CONFIRM THE REPORTED ISSUE. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THERE WAS NO KNOWN PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE GAS BLENDER. THE INCIDENT OCCURRED IN USA. A LIVANOVA SERVICE TECHNICIAN PERFORMED THE PMG AND CONFIRM THE REPORTED ISSUE. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H.10: THE REPORTED ISSUE OCCURRED ON A DEVICE WHICH WAS NOT IN POSSESSION OF THE CUSTOMER AND THAT WAS WAITING FOR RECONDITIONING PROCESS IN ARVADA FACILITY AND TEST BEFORE RECONDITIONING FAILED. THE PMG CHECKLIST WAS PROVIDED AND EXPECTED OUTPUT GAS VALUES (FOR 5 LMP AND 9 LPM) WERE CONFIRMED TO BE OUT OF SPECIFICATION. THE INVOLVED UNIT WAS RETURNED TO LIVANOVA DEUTSCHLAND AND CHECKED. THE SAME TESTS FORESEEN BY THE PMG WERE REPEATED: NO DEVIATIONS WERE DETECTED. ALL VALUES WERE FOUND TO BE WITHIN SPECIFICATION AND NO HARDWARE DEFECTS WERE DETECTED DURING THE FUNCTIONAL TEST. BASED ON ALL THE ABOVE FACTS, THE DEVICE DID NOT MALFUNCTION AND THE MOST LIKELY ROOT CAUSE CAN BE TRACED TO PMG TESTS NOT CORRECTLY CARRIED OUT IN LIVANOVA ARVADA. THE AFFECTED DEVICE WAS RE-CALIBRATED AND RETURNED TO LIVANOVA ARVADA.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED A REPORT ABOUT ELECTRONIC GAS BLENDER FAILED ON THE TOLERANCES PROVIDED. NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED A REPORT ABOUT ELECTRONIC GAS BLENDER FAILED ON THE TOLERANCES PROVIDED. NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494151 S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX LIVANOVA DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown