BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SET # 724

    MDR report key: 1258466 · Received December 1, 2008

    Report

    Report Number
    MW5009136
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    November 29, 2008
    Report Date
    December 1, 2008
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PIECE OF EQUIPMENT IS THE EM 2400 TPN COMPOUNDER MADE BY THE BAXA CORP. WHEN THE VALVE SET WAS PLACED ON THE EM2400, THERE WAS A WARNING DURING THE VERIFICATION PROCESS OF AN AIR BUBBLE/OCCLUSION. WHEN THE OK BUTTON WAS PRESSED, THE COMPOUNDER WENT ON AS NORMAL. AFTER 3 PEDIATRIC/NEONATAL TPN'S WERE PUMPED, A VIAL OF SODIUM PHOSPHATE WAS EMPTY. WHEN THE TECHNICIAN RUNNING THE MACHINE WAS NOTIFIED BY THE COMPOUNDER TO REPLACE THE VIAL, HE IMMEDIATELY NOTIFIED THE PHARMACIST OF THE ABNORMALITY. A TOTAL OF APPROX 2 ML OF SODIUM ACETATE SHOULD HAVE BEEN DELIVERED TO THE COMPOUNDED TPN'S WITH AN ADDITIONAL UNK VOLUME THAT WAS USED TO PRIME THE TUBING. THE REMAINDER OF VIAL THAT WAS SPREAD AMONG 3 TPNS. AFTER A TPN IS PUMPED, A MIX CHECK REPORT PRINTS OUT WITH THE INGREDIENTS PUMPED AND THE PERCENT DIFFERENCE BETWEEN CALCULATED VERSUS ACTUAL WEIGHT ON THE REPORT. IN REVIEWING THE MIX CHECK REPORT, NOTHING APPEARED ABNORMAL AND ALL WERE WITHIN THE ACCEPTABLE RANGE. WE DISCARDED THE TPN'S THAT HAD BEEN MADE ENSURING THEY NEVER MADE IT OUT OF THE PHARMACY AND REPLACED THE TUBE SET. WHEN THIS WAS DONE, A SMALL CHINK WAS NOTICED ON THE #3 VALVE. THIS WOULD PROBABLY HAVE NOT ALLOWED THE VALVE TO CLOSE COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE SET # 724 NONE LHI BAXA CORPORATION 724

    Patients

    Seq Age Sex Outcome Treatment
    1