BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM CLAVE 4 GANG 1O2 MANIFOLD ADMIN SET

    MDR report key: 2428738 · Received December 22, 2011

    Report

    Report Number
    2025816-2011-00035
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 24, 2011
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE REPORTED PRODUCT PROBLEMS AND CONCERNS WERE EVALUATED. THE ROOT CAUSE WAS IDENTIFIED AS A DESIGN/CONFIGURATION ISSUE. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. THESE REPORTS AND THE ASSOCIATED INFORMATION HAVE BEEN ENTERED IN OUR DATABASE FOR ANALYSIS, MONITORING AND TRENDING.

    Description of Event or Problem · 1

    COMPLAINT REC'D. REPORTING KINKING/FLOW/MISSING COMPONENT PROBLEMS WITH USE OF B5193 CUSTOM CLAVE 4 GANG 1O2 MANIFOLD ADMIN. SETS. IT WAS REPORTED THAT "SETS WERE "KINKING OFF" ON BOTH SIDES OF THE 1O2 MANIFOLD." ADDITIONAL PROBLEMS NOTED THAT THE SETS TOP Y-SITE DID NOT HAVE A BACK CHECK VALVE AND DRUG WENT UP LINE TOWARDS THE IV BAG." THE B5193 DEVICE SETS WERE REMOVED AND REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. MFR'S DEVICE ANALYSIS: AN TOTAL OF TOUR (4) PACKAGED B5193 ADMIN SETS, TWO EACH FROM THE REPORTED LOTS 2082921 AND 2082922 WERE RECEIVED. VISUAL ANALYSIS: THE INITIAL RESULTS RECORDED NO OBVIOUS ABNORMALITIES WITH THE SETS/COMPONENTS. THERE WAS NO VISUAL EVIDENCE OF KINKED TUBING AT THE SETS 1O2 END ON THE PACKAGED SAMPLES THAT WERE RETURNED. CONFIGURATION ANALYSIS: THE B5193 SETS CONFIGURATION AND ASSEMBLY DRAWINGS WERE THAN REVIEWED AND ANALYZED. THE RETURNED SETS FROM LOT # 2082922 AND 2082921 WERE ASSEMBLED CORRECTLY PER THE APPLICABLE SET DRAWINGS. A REVIEW OF THE QUOTE CENTER SET DESIGN HISTORY FILES IDENTIFIED CUSTOMER/FACILITY EVALUATED SEVERAL DIFFERENT CONFIGURATIONS, BOTH WITH AND WITHOUT THE CHECK VALVE ABOVE THE FIRST Y-CLAVE, BELOW THE DRIP CHAMBER. THE FINAL SET CONFIGURATION/DESIGN APPROVED AND EVALUATED BY THE FACILITY DID NOT FEATURE A CHECK VALVE BETWEEN THE DRIP CHAMBER AND CLAVE. THE REPORTED MISSING BACK CHECK VALVE (BCV) WAS CONFIRMED. FUNCTIONAL AND PERFORMANCE TESTING WAS CONDUCTED. THE TEST RESULTS DID RECORD THE B5193 SETS Y-CLAVE (NEAREST THE DRIP CHAMBERS) ALLOWED FLUID TO BACK UP INTO THE DRIP CHAMBERS. THE REPORTED FLOW ISSUE WAS CONFIRMED. THE REPORT NOTED THIS FLOW CONDITION OCCURRED SINCE THERE WAS NO BCV PRESENT. DURING BOTH PRIMING AND FLOW TESTING, THERE WAS NO EVIDENCE OF TUBING/KINKING ISSUES. THIS CUSTOM SET HAS BEEN REDESIGNED. THE NEW SET DESIGN INCORPORATES (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM CLAVE 4 GANG 1O2 MANIFOLD ADMIN SET ADMINISTRATION SET FMG ICU MEDICAL INC. B5193 2082921; 2082922

    Patients

    Seq Age Sex Outcome Treatment
    1