BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTA-MIX 2400

    MDR report key: 1743859 · Received June 30, 2010

    Report

    Report Number
    1419106-2010-00014
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 9, 2010
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ABLE TO PROVIDE THEIR EM2400 COMPOUNDER DATABASE AND BLACKBOX DATA, THE PHYSICIAN'S ORDER, AS WELL AS COPIES OF THE LABELS PRODUCED BY ABACUS FOR THE SUBJECT BAG. AN EVAL OF THE COMPOUNDER MIXCHECK REPORT AND THE ABACUS SOLUTION LABEL FOR THE SUBJECT BAG INDICATES THAT THE COMPOUNDER DELIVERED POTASSIUM AS ORDERED IN ABACUS (110 MEQ/L). THE MIXCHECK REPORTS INDICATE THAT THE TOTAL COMPOUNDED VOLUMES OF THE SUBJECT BAG WERE ACCURATELY DELIVERED WITHIN ACCEPTABLE RANGE (+/-3% OF THE ORDERED VOLUMES). IN ORDER TO INVESTIGATE THE ISSUE, THE ADDITIONAL FOLLOWING ITEMS WERE EVALUATED: THE PHYSICIAN'S ORDER FORM: THIS FORM CONTAINS INFO ABOUT THE SUBJECT PT AND A LIST OF THE REQUIRED INGREDIENTS THAT ARE NEEDED IN THE SUBJECT BAG. RESULTS OF EVAL: THE PHYSICIAN'S ORDER HAS INSTRUCTIONS TO INCLUDE 110 MEQ/L OF POTASSIUM IN THE SUBJECT BAG. THE EM2400 BLACKBOX DATA: THE COMPUTER RUNNING THE COMPOUNDER OPERATING SOFTWARE AND THE COMPOUNDER ITSELF MAINTAIN AN ONGOING DIALOGUE THAT IS RECORDED IN A "BLACKBOX" FILE. THIS PROVIDES AN AUDIT TRAIL FOR REFERENCE. RESULTS OF EVAL: A COMPLETE REVIEW OF THE BLACKBOX DATA SHOWED THAT THE COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUMES OF THE REQUESTED INGREDIENTS FOR THE SUBJECT BAG. THERE WERE NO UNUSUAL EVENTS IN THE DEVICE HISTORY OR INFO THAT MIGHT RELATE TO THE REPORTED INCIDENT. THE CUSTOMER WAS CONTACTED AND PROVIDED WITH THE RESULTS OF OUR DOCUMENTATION AND DATA REVIEW. THE CUSTOMER THEN PROVIDED ADDITIONAL INFO STATING THAT A ROOT CAUSE ANALYSIS WAS COMPLETED AT THEIR FACILITY FOR THIS INCIDENT. IT WAS DETERMINED THAT THE SUBJECT TPN CREATED BY THE ABACUS CALCULATING SOFTWARE AND EM2400 COMPOUNDER DID NOT CAUSE OR CONTRIBUTE TO THIS INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, BAXA WAS NOTIFIED BY THE CUSTOMER OF A PT INVOLVED INCIDENT USING THE ABACUS V2.0 TPN CALCULATING SOFTWARE AND THE EXACTA-MIX 2400 COMPOUNDER FOR TPN PRODUCTION. DURING (B)(6) 2010, TPN FEEDING WAS ADMINISTERED TO A PT WHO SUBSEQUENTLY SUFFERED FROM HYPERKALEMIA (HIGH LEVEL OF POTASSIUM). THE PT BECAME LETHARGIC, LIMP AND THEN WENT INTO CARDIAC ARREST. THE PT WAS RESUSCITATED AND GIVEN A DOPAMINE DRIP, ARTERIAL LINE, CVP LINE AND VENTILATED FOR SEVERAL DAYS IN THE PICU. THE PT BECAME STABLE, BUT HAS SINCE DECEASED, PER PT'S FAMILY REQUEST TO WITHDRAW CARE FOR REASONS NOT RELATED TO THIS INCIDENT.

    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 11 MO Life Threatening