BEUDAMED
    FDA Adverse Event Death Summary report: N

    EM 2400, MAIN MODULE

    MDR report key: 6826630 · Received August 29, 2017

    Report

    Report Number
    1416980-2017-06982
    Event Type
    Death
    Date Received
    August 29, 2017
    Report Date
    December 8, 2017
    Manufacturer
    BAXTER HEALTHCARE - ENGLEWOOD
    Product Code
    NEP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT DIED AFTER RECEIVING A PRODUCT COMPOUNDED BY AN EXACTAMIX 2400 MAIN COMPOUNDER MODULE. THE CAUSE OF DEATH WAS NOT REPORTED. THE PRODUCT/TYPE OF COMPOUNDED DRUG WAS NOT SPECIFIED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF THERAPY WAS ONGOING PRIOR TO DEATH OR IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607204 EM 2400, MAIN MODULE SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE - ENGLEWOOD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death