BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1

    MDR report key: 11851444 · Received May 19, 2021

    Report

    Report Number
    3012307300-2021-04647
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    January 22, 2021
    Report Date
    August 24, 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, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL FLUID WARMING: LEVEL 1 HOTLINE ACCESSORIES WITH TWO PICTURES ATTACHED FOR EVALUATION. THE RESULTS FROM THE PICTURES REVEAL LIQUID IN THE FILTER. DURING TESTING WITH SAMPLE UNIT, IT WAS DISCOVERED LEAKING DETECTED IN VALVE DISC. 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 TO THE PRODUCTION PERSONNEL IN ORDER TO AVOID THE OVERSIGHT THE ADHESIVE OPERATION

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARY IN H10.

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GAS VENT WAS LEAKING FLUID FROM THE FILTER. THE PRODUCT PROBLEM WAS OBSERVED DURING PATIENT USE. THE PRODUCT FAULT DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE PATIENT HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745406 LEVEL 1 WARMER, THERMAL, INFUSION FLUID LGZ L-10 40695085401002

    Patients

    Seq Age Sex Outcome Treatment
    1