BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXACTA-MIX 2400

    MDR report key: 1218464 · Received October 31, 2008

    Report

    Report Number
    1419106-2008-00014
    Event Type
    Death
    Date Received
    October 31, 2008
    Date of Event
    September 20, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GOVERNMENT HAS PERFORMED AN INQUIRY INTO THE INCIDENTS AND THE OUTCOME IS EXPECTED TO BE PUBLISHED SHORTLY. ALTHOUGH BAXA EQUIPMENT WAS USED TO COMPOUND THE TPN SOLUTIONS, NEITHER BAXA NOR THE DISTRIBUTOR OF THE EQUIPMENT HAVE BEEN INVOLVED IN THE INQUIRY. THERE HAS BEEN NO SUGGESTION THAT THE EQUIPMENT MALFUNCTIONED OR WAS AT FAULT IN ANY WAY. THERE HAVE BEEN NO REPORTS OF SIMILAR INCIDENTS IN ANY OTHER MARKET, AND EXAMINATION OF THE TRACEABILITY RECORDS INDICATE NO ISSUES WITH STERILITY OR MALFUNCTION OF THE EQUIPMENT INVOLVED. AN EXAMINATION OF THE EM2400 DATABASE SHOW NO UNUSUAL EVENTS IN THE DEVICE HISTORY OR INFORMATION THAT MIGHT RELATE TO THE REPORTED INCIDENTS. A REVIEW OF STERILIZATION DATA FOR THE DISPOSABLES THAT MAY HAVE BEEN USED SHOW NO DISCREPANCIES OR UNUSUAL INFORMATION. THROUGH OUR INVESTIGATION SO FAR, WE DO NOT HAVE INFORMATION SUGGESTING THAT THE EM2400 CAUSED OR CONTRIBUTED TO THESE PATIENT DEATHS AS A RESULT OF FAILURE, MALFUNCTION, IMPROPER OR INADEQUATE DESIGN, MANUFACTURE, OR LABELING OF THE PRODUCT. IF BAXA RECEIVES ADDITIONAL INFORMATION IN REGARDS TO THIS INCIDENT, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXA WAS NOTIFIED ON 10/06/2008 OF AN INCIDENT AT A HOSPITAL. DURING 2 DAYS IN 2008, TPN FEEDING WAS ADMINISTERED TO 35 PREMATURE BABIES; 13 OF WHOM SUBSEQUENTLY DIED. FIVE OF THESE WERE RELATED TO SEPTICEMIA, POSSIBLY DUE TO CONTAMINATED TPN SOLUTIONS. THE CAUSE OF DEATH OF THE REMAINDER IS CURRENTLY NOT KNOWN. FOUR UNUSED TPN BAGS WERE SUBSEQUENTLY FOUND TO CONTAIN ENDOBACTERIA, DIRECTLY RELATED TO POOR HYGIENE; EITHER FROM TRANSPORTATION, STORAGE OR APPLICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death