BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXACTA-MIX 2400 COMPOUNDING SYSTEM

    MDR report key: 969196 · Received December 26, 2007

    Report

    Report Number
    1419106-2007-00025
    Event Type
    Death
    Date Received
    December 26, 2007
    Date of Event
    November 29, 2006
    Report Date
    November 30, 2006
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXA PERFORMED AN INVESTIGATION OF THE ELECTRONIC DATA CREATED BY THE COMPOUNDING SYSTEM. DURING THIS REVIEW, ALL ASPECTS OF PUMP OPERATION WERE EVALUATED FOR THE SUBJECT BAG AND ALL DATA INDICATES THAT THE PUMP OPERATED AS DESIGNED WITHOUT ANY ANOMALIES. IN ADDITION, NO OTHER INFORMATION COMMUNICATED TO BAXA, SUGGESTS THAT THE EM2400 DELIVERED ANY INGREDIENT, INCLUDING CALCIUM, PHOSPHATE, OR PROTEIN OUTSIDE OF THE ACCEPTABLE OPERATING RANGE OF THE PUMP DURING PRODUCTION OF THE SUBJECT BAG. IT HAS BEEN CONCLUDED THAT EXACTA-MIX 2400 COMPOUNDER OPERATED AS DESIGNED DURING THE REPORTED INCIDENT. THE CUSTOMER WAS NOTIFIED OF THE ANALYSIS RESULTS AND TRANSFERRED THE INFORMATION TO THE REQUESTING HOSPITAL. NO FURTHER FEEDBACK HAS OCCURRED.

    Description of Event or Problem · 1

    THIS MDR IS BEING FILED RETROSPECTIVELY. AFTER A REVIEW OF PRIOR COMPLAINT INFORMATION, THIS INCIDENT WAS DETERMINED TO BE REPORTABLE. IN 2006, BAXA WAS NOTIFIED THAT AN UNEXPECTED PATIENT DEATH OCCURRED. IT WAS REPORTED THAT THE PATIENT WAS RECEIVING TPN THERAPY AT THE TIME OF THE INCIDENT. THE HOSPITAL INDICATED TO THE COMPOUNDING CENTER THAT A SERUM TEST HAD SHOWN THAT THE PATIENT HAD ELEVATED LEVELS OF CALCIUM, POTASSIUM AND PROTEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400 COMPOUNDING SYSTEM EM2400 COMPOUNDER LHI BAXA CORP. 2400-D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death