BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE SET, EM2400

    MDR report key: 14681073 · Received June 13, 2022

    Report

    Report Number
    1416980-2022-03080
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 19, 2022
    Report Date
    June 13, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    UDI-DI
    00085412477183
    PMA / PMN Number
    K002705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS: (B)(6). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H4: THE LOT WAS MANUFACTURING MARCH 30, 2022 TO MARCH 31, 2022. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE TRACE ELEMENTS (MTE) WERE LEAKING INTO AN EM2400 VALVE SET. THIS ISSUE WAS IDENTIFIED DURING PREPARATION/COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248842 VALVE SET, EM2400 SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA 60358697 00085412477183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown