BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1

    MDR report key: 11691051 · Received April 19, 2021

    Report

    Report Number
    3012307300-2021-03266
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 1, 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

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL FLUID FLUID WARMING/LEVEL 1 HOTLINE ACCESSORIES PICTURES ATTACHED REVEALED LIQUID IN THE FILTER. UNIT RECEIVED FOR TESTING REVEALED LEAK IN THE VALVE DISC. DEVICE PASSED ALL FUNCTIONAL TESTING PRIOR TO RELEASE OF PRODUCT. THE EVENT DESCRIPTION PROVIDED PER CUSTOMER STATED: ?DURING A PRE-USE CHECK, THE CUSTOMER FOUND LEAKAGE OF MEDICAL FLUID FROM THE PRODUCT, WHICH DID NOT ALLOW HIM TO USE IT. NO PATIENT INJURY..?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.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARY.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL FLUID WARMING ACCESSORY FOUND A LEAKAGE OF MEDICAL FLUID FROM THE PRODUCT DURING A PRE-USE CHECK. THERE WAS NO PATIENT PRESENT. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581318 LEVEL 1 WARMER, THERMAL, INFUSION FLUID LGZ L-10 4025990 40695085401002

    Patients

    Seq Age Sex Outcome Treatment
    1