BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTA-MIX 2400

    MDR report key: 1570985 · Received January 4, 2010

    Report

    Report Number
    1419106-2009-00023
    Event Type
    Other
    Date Received
    January 4, 2010
    Date of Event
    December 3, 2009
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SITE VISIT WAS CONDUCTED TO EVALUATE THE EQUIPMENT AND IT WAS DETERMINED THAT THE EXACTA-MIX 2400 COMPOUNDER WAS OPERATING AS INTENDED. IT WAS RECOMMENDED THAT BAXA PROVIDE THE FACILITY RE-TRAINING FOR THEIR PHARMACY STAFF IN THE USE OF THE EXACTA-MIX 2400 COMPOUNDER AND THE ASSOCIATED EXACTA-MIX 2400 COMPOUNDER SOFTWARE. IT WAS ALSO NOTED THAT DURING THIS SITE VISIT THAT MANY (B)(6) WERE NOT BEING FOLLOWED, AS WELL AS FACILITY GENERATED PROCEDURES AND PROTOCOLS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, BAXA WAS NOTIFIED BY THE CUSTOMER OF A PATIENT INVOLVED INCIDENT USING THE EXACTA-MIX 2400 COMPOUNDER FOR TPN AND DIALYSATE PRODUCTION. SOMETIME ON (B)(6) 2009, HOSPITAL STAFF NOTED THAT THE ECMO AND DIALYSIS PATIENT'S SERUM SODIUM LEVELS STARTED DROPPING INTO THE 130S, ALTHOUGH THE THERAPEUTIC GOAL WAS A SERUM SODIUM CLOSE TO 145. SINCE THE PATIENT'S SERUM SODIUM LEVELS CONTINUED TO DECREASE OVER THE NEXT 2HRS, THEY DECIDED TO CHECK THE SODIUM IN THE DIALYSATE AT THE BEDSIDE WITH THE I-STAT MACHINE. THEY ALSO SENT A SAMPLE TO THE LAB (LIKE THE I-STAT, THE LAB'S EQUIPMENT IS ALSO DESIGNED TO MEASURE SERUM LEVELS). THE RESULTS OF THE TESTS SHOWED THAT THE SODIUM LEVEL IN THE DIALYSATE AND REPLACEMENT BAGS WAS BELOW EXPECTED. THE PATIENT'S DIALYSATE AND REPLACEMENT BAGS WERE REMADE, ALL MAINTENANCE FLUIDS WERE REPLACED WITH SODIUM BASED SOLUTIONS, AND SODIUM BOLUSES WERE PROVIDED AS NEEDED TO RETURN THE PT'S SERUM SODIUM LEVELS TO THE THERAPEUTIC GOAL. PER THE CICU PHARMACIST DIRECTLY INVOLVED IN THE PATIENT'S CARE, THE SITUATION WAS RESOLVED WITHIN TWO HOURS. NO LONG TERM MEDICAL INTERVENTION WAS NEEDED AND NO APPARENT LONG-TERM INJURY OR ILLNESS RESULTED FROM THIS ISSUE. THE SODIUM BICARBONATE ORDERED FOR THE DIALYSATE AND REPLACEMENT SOLUTIONS WAS TO BE ADDED MANUALLY BY THE PHARMACY (NOT PUMPED BY THE COMPOUNDER) AS IT IS NOT INCLUDED ON THE COMPOUNDER CONFIGURATION. THE PHARMACIST DIRECTLY INVOLVED WITH THIS PATIENT'S CARE BELIEVES THAT A FAILURE TO COMPLETE THE MANUAL ADDITION OF THE SODIUM BICARBONATE OCCURRED, WHICH WAS THE MOST LIKELY SOURCE OF THE UNDER DELIVERY OF SODIUM, AND THAT IT WAS NOT CAUSED BY THE PERFORMANCE OF THE COMPOUNDER ITSELF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention