BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXACTA-MIX 2400 COMPOUNDER

    MDR report key: 1689815 · Received May 12, 2010

    Report

    Report Number
    1419106-2010-00011
    Event Type
    Death
    Date Received
    May 12, 2010
    Date of Event
    April 17, 2010
    Report Date
    April 19, 2010
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DATABASE AND PT REPORTS WERE REVIEWED. NONE OF THESE ITEMS SUGGEST THAT THE COMPOUNDER CAUSED OR CONTRIBUTED TO THIS PT DEATH AS A RESULT OF FAILURE, MALFUNCTION, IMPROPER OR INADEQUATE DESIGN, MANUFACTURE, OR LABELING OF THE PRODUCT. AN EMAIL RECEIVED FROM THE IV SUPERVISOR AT THE USER FACILITY ON 04/20/2010 STATED: "NEONATOLOGIST HAS RULED OUT TPN AS A POSSIBLE CAUSE OF DEATH."

    Description of Event or Problem · 1

    ON 04/19/2010, BAXA WAS NOTIFIED BY A CUSTOMER OF A PT INVOLVED INCIDENT. THE PT DIED ON (B) (6) 2010. THE CUSTOMER USES THE EXACTA-MIX 2400 COMPOUNDER FOR TPN PRODUCTION. THE INITIAL CUSTOMER REPORTING THE ADVERSE EVENT IS A COMPOUNDING FACILITY. UPON FURTHER FOLLOW UP WITH THE HOSPITAL WHERE THE EVENT OCCURRED, THE NEONATOLOGIST RULED OUT TPN AS A POSSIBLE CAUSE OF DEATH, AND STATES THE INCIDENT WAS NOT DUE TO BAXA'S COMPOUNDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400 COMPOUNDER EXACTA-MIX 2400 COMPOUNDER LHI BAXA CORP. 2400-M

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Death