BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX

    MDR report key: 20658892 · Received November 11, 2024

    Report

    Report Number
    1416980-2024-06459
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Report Date
    April 22, 2025
    Manufacturer
    LHI
    Product Code
    LHI
    UDI-DI
    00085412475783
    PMA / PMN Number
    K002705
    Removal / Correction Number
    3002710954-08/09/24-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H6, AND H11: H11: THE REPORTED PROBLEM AND THE LOT NUMBER COMBINATION IS THE SAME FAILURE ALREADY DOCUMENTED IN A FIELD ACTION FA-2024-050. THE INVESTIGATION HAS BEEN PERFORMED AND IDENTIFIED THE CAUSES OF THE REPORTED PARTICULATE MATTER WITHIN THE INLET PRIMARY PACKAGING INLET COMPONENTS (INCLUDING WITHIN THE STERILE FLUID PATH TUBING) ARE RELATED TO MULTIPLE ROOT CAUSES ASSOCIATED WITH PROCESS/PROCEDURAL CONTROLS, MATERIALS, ENVIRONMENT, AND MACHINE/TOOLING DURING MANUFACTURING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED UNSPECIFIED PARTICULATE WAS OBSERVED IN SEVEN (7) NON-VENTED HIGH-VOLUME INLETS. THIS WAS OBSERVED DURING INSPECTION, PRIOR TO ENTERING THE STERILE COMPOUNDING ENVIRONMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539580 EXACTAMIX SET, I.V. FLUID TRANSFER LHI LHI H938173 803782 00085412475783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown