BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1

    MDR report key: 11623002 · Received April 6, 2021

    Report

    Report Number
    3012307300-2021-02880
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 8, 2021
    Report Date
    August 18, 2021
    Product Code
    LGZ
    UDI-DI
    40695085401002
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL FLUID WARMING/LEVEL 1 HOTLINE ACCESSORIES COMPLAINT OF LEAKING WAS CONFIRMED WITH TESTING WITH SYRINGE. THE CAUSE IS BELIEVED TO BE AFTER SAMPLE EVALUATION THE MOST PROBABLE ROOT CAUSE FOR THE LEAK CONDITION IN VALVE DISC IS DUE TO A OPERATOR OVERSIGHT THE OPERATION ADHESIVE (LOCTITE 495) IN THE VALVE DISC, DURING DISC APPLICATION PROCESS, PROCEDURE MP L-10 OPERATION 4.7 ?USING LOCTITE 495 AND EFD SOLVENT DISPENSER (1000SERIES), STEP ON FOOT PEDAL TO APPLY SINGLE DROPLET OF LOCTITE 495 TO CENTER OF VENT DISC SEAT OR ?CASTLE RING" ON GAS VENT BODY." WAS NOT CORRECTLY FOLLOWED. AN AWARENESS NOTIFICATION WAS CONDUCTED BY THE QUALITY ENGINEER.

    Description of Event or Problem · 0

    DEVICE EVALUATION COMPLETED AND SUMMARY IN H 10.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY ON USE OF A SMITHS MEDICAL LEVEL 1 HOTLINE ACCESSORY, THE CUSTOMER NOTICED THAT MEDICAL FLUID WAS LEAKING FROM THE AIR VENT FILTER. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520673 LEVEL 1 WARMER, THERMAL, INFUSION FLUID LGZ L-10 4033690 40695085401002

    Patients

    Seq Age Sex Outcome Treatment
    1