BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE QUADFUSE W/.2 MICRON FILTER IV SET

    MDR report key: 1913010 · Received November 18, 2010

    Report

    Report Number
    2025816-2010-00098
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 21, 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 TWO (2) B33206 12" SMALLBORE QUADFUSE EXT SETS .2 MICRON FILTERS WERE CRACKED/DAMAGED RESULTING IN TPN/FLUID LEAKAGE. THE DEVICES WERE MATED/IN USE WITH B BRAUN PUMP SETS. THE REPORT CITES A 7/20 INCIDENT WHERE "..DUE TO THE CRACK, THE TPN/FLUIDS WAS NOT INFUSING INTO THE PT, BUT RATHER INTO THE BED. AS A RESULT THE PT BECAME HYPOGLYCEMIC AND REQUIRED D10 BOLUSES TO BRING SUGAR BACK UP. ... THIS ISSUE HAS OCCURRED TWICE..." IN BOTH INCIDENTS, PTS. RETURNED TO BASELINE CONDITION. THE DEVICE SETS WERE REMOVED AND REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. 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. ADDITIONAL ANALYSIS DOCUMENTS THAT PER THE B33206 DFU USE OF TPN WITH LIPIDS OR LIPIDS ALONE SHOULD BE ADMINISTERED WITH A 1.2 MICRON INLINE FILTER. THIS SET IS CONFIGURED WITH A .2 MICRON FILTER. THE EXACT CAUSE OF THE PROBLEM IS UNK.

    Devices

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

    Patients

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