BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLINTEC COMPUTER INTEGRATED COMPOUNDING SYSTEM

    MDR report key: 217175 · Received April 2, 1999

    Report

    Report Number
    6000001-1999-00121
    Event Type
    Death
    Date Received
    April 2, 1999
    Date of Event
    December 31, 1998
    Report Date
    March 3, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP. - CLINTEC
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED, VIA MANDATORY MEDWATCH, THAT TWINS, 24 WEEKS GESTATION, WEIGHT 652 AND 579 GRAMS, ONE WITH AN INTRAVENTRICULAR BRAIN HEMORRHAGE AND THE OTHER WITH A PATENT DUCTUS VENOSUS, DIED NINE DAYS AFTER BIRTH. APPARENTLY, THEY WERE RECEIVING HEPARINIZED SALINE, PREPARED USING THE COMPOUNDER EQUIPPED WITH COMPUTER SOFTWARE. THE MEDWATCH ALLEGES SEVERAL PROBLEMS WITH THE SOFTWARE. THE LINK BETWEEN THE DEATHS AND THE SOFTWARE IS NOT EXPLICITLY STATED IN THE MEDWATCH. APPARENTLY, 77MEQ OF SODIUM CHLORIDE WERE ADDED TO THE BAGS GIVEN TO THE NEONATES, FOR A CONCENTRATION OF 77MEQ/124ML. HALF NORMAL SALINE IS 77MEQ/L. PT'S WEIGHT IS 620 GRAMS.

    Description of Event or Problem · 2

    CUSTOMER REPORTED, VIA MANDATORY MEDWATCH, THAT TWINS, 24 WEEKS GESTATION, WEIGHT 652 AND 579 GRAMS, ONE WITH AN INTRAVENTRICULAR BRAIN HEMORRHAGE AND THE OTHER WITH A PATENT DUCTUS VENOSUS, DIED NINE DAYS AFTER BIRTH. APPARENTLY, THEY WERE RECEIVING HEPARINIZED SALINE, PREPARED USING THE COMPOUNDER EQUIPPED WITH COMPUTER SOFTWARE. THE MEDWATCH ALLEGES SEVERAL PROBLEMS WITH THE SOFTWARE. THE LINK BETWEEN THE DEATHS AND THE SOFTWARE IS NOT EXPLICITLY STATED IN THE MEDWATCH. APPARENTLY, 77MEQ OF SODIUM CHLORIDE WERE ADDED TO THE BAGS GIVEN TO THE NEONATES, FOR A CONCENTRATION OF 77MEQ/124ML. HALF NORMAL SALINE IS 77MEQ/L. PT'S WEIGHT IS 605 GRAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINTEC COMPUTER INTEGRATED COMPOUNDING SYSTEM COMPUTER SOFTWARE LHI BAXTER HEALTHCARE CORP. - CLINTEC NA M0S2.3E

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DAY Death
    2 9 DAY Death