BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EM 2400, MAIN MODULE

    MDR report key: 14981320 · Received July 11, 2022

    Report

    Report Number
    1416980-2022-03570
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 19, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    NEP
    UDI-DI
    00085412609034
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO D4: MODEL #. G1: MANUFACTURING FACILITY. CORRECTION MADE TO B5: THE REPORTED ISSUE OCCURRED WITH THE EM 2400, MAIN MODULE (PREVIOUSLY SUBMITTED AS AUTOMATED COMPOUNDING DEVICE). CORRECTION MADE TO D1: BRAND NAME: EM 2400, MAIN MODULE (PREVIOUSLY SUBMITTED AS EM2400 DY V1.13 DISPLAY). CORRECTION MADE TO G1: BAXTER HEALTHCARE - ENGLEWOOD 14445 GRASSLANDS DR ENGLEWOOD CO 80112 UNITED STATES (PREVIOUSLY SUBMITTED AS PLEXUS CORPORATION 2500 MILLBROOK DRIVE BUFFALO GROVE IL 60089 UNITED STATES). CORRECTION MADE TO G4: PMA/510K # OR BLA #: NA (PREVIOUSLY SUBMITTED AS NI). H10: THE DEVICE WAS NOT RETURNED THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIPIDS WERE LEAKING FROM PORT 2 OF AN AUTOMATED COMPOUNDING DEVICE INTO THE FINAL BAG. CLINILIPID WAS ON PORT 1 AND SMOFLIPID WAS ON PORT 2 DURING COMPOUNDING AT THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396114 EM 2400, MAIN MODULE SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE CORPORATION 2400M NA 00085412609034

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown