BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE QUADFUSE W/.2 MICRON FILTER IV SET

    MDR report key: 1913003 · Received November 18, 2010

    Report

    Report Number
    2025816-2010-00117
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING PROBLEMS WITH USE OF CUSTOM B33206 12" SMALLBORE QUADFUSE EXT SETS .2 MICRON FILTERS FOUND TO BE CRACKED/DAMAGED RESULTING IN TPN/FLUID LEAKAGE. THE DEVICES WERE MATED/IN USE WITH B BRAUN PUMP SETS. IT WAS REPORTED THAT "THE .22 FILTER WAS LEAKING, CAUSING THE FLUIDS TO INFUSE INTO THE BED AND NOT THE PT-THIS HAS CAUSED INSTANCES WHERE THE PT BECOME HYPOGLYCEMIC-THEY MUST GIVE BOLUSES OF D10 TO BRING THE PT BACK UP WITH NORMAL RANGE. MFR INVESTIGATION: ONE (1) USED B33206 SET WAS RETURNED FOR ANALYSIS AND INVESTIGATION. VISUAL AND FUNCTIONAL TESTING CONFIRMED LEAKAGE ORIGINATING FROM TWO LONGITUDINAL CRACKS ALONG THE FEMALE LUER OF THE FILTER. THE ENGINEERING ANALYSIS REPORT NOTES THE LUER APPEARS TO HAVE BEEN SUBJECTED TO SOME TYPE OF UNINTENDED FORCE AND/OR OVER-TIGHTENED. CORRECTIVE ACTIONS: A CONFIGURATION CHANGE TO THIS CUSTOM SET TO HAVE THE FILTER ATTACHED IN LINE INSTEAD OF AT THE END OF THE SET WAS MADE. FACILITY CLINICIANS WERE PROVIDED SAMPLES OF THIS CONFIGURATION FOR REVIEW, APPROVAL AND TRAINING. CURRENT BUILD REFLECTS THIS CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALLBORE QUADFUSE W/.2 MICRON FILTER IV SET EXTENSION SET FPA ICU MEDICAL INC. B33206 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI B BRAUN PUMP SET NOI