BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE FLUID WARMING SET

    MDR report key: 13343865 · Received January 25, 2022

    Report

    Report Number
    3012307300-2022-01642
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    December 1, 2021
    Report Date
    June 9, 2022
    Manufacturer
    OAKDALE
    Product Code
    LGZ
    UDI-DI
    30695085407007
    PMA / PMN Number
    K001764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. PICTURES ATTACHED: AS PART OF INVESTIGATION (B)(4) TWO IMAGES WERE PROVIDED. VISUAL INSPECTION RESULTS BASED ON PICTURE: BASED ON IMAGE PROVIDED, THERE IS VISIBLE A LIQUID DROP FROM THE CONNECTION BETWEEN TUBE AND REFLUX CONNECTOR, THIS COULD BE CAUSED BY SOME LEAKAGE IN THE PRODUCT BUT IS NECESSARY PERFORM A FUNCTIONAL TEST TO CONFIRM FAILURE MODE. SAMPLES RECEIVED: ONE (1) SAMPLE UNIT WERE RECEIVED AT SMITHS MTIJ WITH ITS ORIGINAL PACKAGE OPENED FROM P/N L-70 WITH UNKNOWN LOT NUMBER REPORTED IN COMPLAINT. VISUAL INSPECTION: THE SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12? UNDER NORMAL LIGHTING TO RECEIVED UNIT, SEE IMAGES BELOW. RESULTS FOR VISUAL INSPECTION IN SAMPLE PROVIDED: NO MARKS OR STAINS WERE OBSERVED ON TUBE SURFACE, NEITHER ON REFLUX CONNECTOR OR SWIVEL CONNECTOR. IT WAS OBSERVED A DELAMINATION BETWEEN Y-INJ, NON-LATEX P/N 10007589-001 AND TUBE P/N 00-166-96. THIS CONDITION COULD CAUSE LEAKAGE, A FURTHER ANALYSIS NEEDS TO BE PERFORMED. RESULTS FOR FUNCTIONAL TEST IN SAMPLE PROVIDED: BASED ON MANUFACTURING PROCEDURE MP L-70 REV.117 AND FAILURE MODE REPORTED, WE PERFORMED A LEAKAGE TEST ON SAMPLE PROVIDED, IN ORDER TO VERIFY IF LEAKAGE CAN BE CONFIRMED WHICH CAN BE CAUSED BY CRACKING ON LUER CONNECTOR DETECTED PREVIOUSLY IN VISUAL INSPECTION, AFTER TEST WAS PERFORMED TO THE PIECE, SAMPLES DOESN?T PASS SUCCESSFULLY LEAKAGE TEST. CONCLUSIONS: BASED ON THE LEAK TEST RESULTS, THE REPORTED NONCONFORMANCE IS CONFIRMED. BASED ON THE ANALYSIS ON SAMPLE PROVIDED, ROOT CAUSE IS LACK OF SOLVENT BY NOT FOLLOWED TO PROCEDURE MANUFACTURING PROCEDURE MP L-70 REV.117 THE CAUSE OF THE REPORTED PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE LEAKED DURING USE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663104 LEVEL 1 HOTLINE FLUID WARMING SET WARMER, THERMAL, INFUSION FLUID LGZ OAKDALE L-70 30695085407007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown