BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROMACRO COMPOUNDING SYSTEM

    MDR report key: 306064 · Received November 23, 2000

    Report

    Report Number
    1419106-2000-00001
    Event Type
    Death
    Date Received
    November 23, 2000
    Date of Event
    September 19, 2000
    Report Date
    October 20, 2000
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A HOSP PHARMACIST CALLED BAXA CORP AND REPORTED THAT THEY HAD AN OCCURRENCE WHICH HAPPENED IN 2000, AND THEY WANTED TO KNOW IF CO COULD CHANGE THE FORMAT OF THE MIX CHECK REPORT. THE PHARMACIST SAID ANOTHER PHARMACIST HAD REC'D AN AMBIGUOUS ORDER FROM A PHYSICIAN FOR A CVVH SOLUTION. THE PHARMACIST SAID THAT THE OTHER PHARMACIST MISINTERPRETED THE ORDER, AND REQUESTED THE WRONG AMOUNT OF CALCIUM FOR THE ORDER. IN ADDITION, WHEN THE PHARMACIST ORDERED, PHARMACIST SELECTED A MEQ CALCIUM PRODUCT INSTEAD OF A MG CALCIUM PRODUCT AND PUT THE MG REQUEST IN THE ORDER ENTRY. THEY SENT AN ALIQUOT OF THE SOLUTION TO THE LAB FOR CONFIRMATION OF CORRECT COMPOUND PRIOR TO ADMINISTRATION TO THE PT. THE LAB CONFIRMED THAT THE SOLUTION CONTAINED THE AMOUNT SPECIFIED ON THE LABEL, BUT NO ONE QUESTIONED WHETHER THE AMOUNT WAS APPROPRIATE. WHEN THE SOLUTION WAS ADMINISTERED, THE PTS CA LEVEL WENT UP TO APPROX 20. THE PT LATER DIES, ALTHOUGH IT WAS NOT CLEAR WHETHER THE CA LEVEL WAS IMPLICATED AS A PRIMARY CAUSE. THE CUSTOMER REPORTED THAT THEY HAD SET WARNING LEVELS IN THE SYSTEM, BUT PHARMACIST COULD NOT ACCESS THE PROGRAM FILE AT THIS TIME TO TELL CO WHAT THEY WERE. THE HOSP DID NOT IMPLY OR SUGGEST THAT THE EQUIPMENT FUNCTIONED IMPROPERLY OR MALFUNCTIONED IN ANYWAY THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMACRO COMPOUNDING SYSTEM PHARMACY COMPOUNDING DEVICE LHI BAXA CORPORATION 072 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death