BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROMACRO 12

    MDR report key: 1844069 · Received September 22, 2010

    Report

    Report Number
    1419106-2010-00018
    Event Type
    Death
    Date Received
    September 22, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON 23AUG2010, BAXA BECAME AWARE OF AN INCIDENT AT (B)(6). THE CUSTOMER USES A MICROMACRO 12 COMPOUNDER FOR TPN PRODUCTION. ON (B)(6)2010, TPN BAGS WERE COMPOUNDED AND ADMINISTERED TO 11 INFANTS; THREE OF WHOM SUBSEQUENTLY DIED DUE TO BACTERIAL CONTAMINATION. DOCTORS GAVE ANTIBIOTICS TO ALL OF THE OTHER BABIES POSSIBLY EXPOSED. ALL OF THE 11 BAGS WERE CONTAMINATED. THE BACTERIA IDENTIFIED WERE ESCHERICHIA HERMANNII AND ENTEROBACTER CLOACAE. ON 27AUG2010, A NEWS CONFERENCE CONFIRMED THAT THE BACTERIA MOST LIKELY CAME FROM A CONTAMINATED BOTTLE DIRTIED DURING TRANSPORT. THEREFORE, IT WAS CONCLUDED THAT BAXA PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMACRO 12 MICROMACRO 12 LHI BAXA CORPORATION 071AE-RS232 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death