BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIROS CONNECTOR

    MDR report key: 1834052 · Received June 1, 2010

    Report

    Report Number
    2025816-2010-00017
    Event Type
    Other
    Date Received
    June 1, 2010
    Date of Event
    January 1, 2010
    Report Date
    January 18, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ICU MEDICAL IS CONTINUING TO INVESTIGATE AND MONITOR DEVICE PERFORMANCE TO ENSURE CORRECTIVE ACTIONS ADDRESS THE PROBLEM THAT WAS REPORTED. OUR CONTINUOUS IMPROVEMENT INITIATIVES PROVIDE ADDITIONAL RESOURCES TO CAPTURE CLINICAL AND MARKETING PREFERENCES FOR DEVICE ENHANCEMENTS AND PERFORMANCE PARAMETERS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED VIA RECEIPT OF (B)(4) REPORTING LEAKAGE PROBLEM WITH 1 NUMBER OF CH2000 SPIROS CONNECTOR. THE REPORT STATES "HUNG DOXORUBICIN PATIENT ALERTED SHE THOUGHT TUBE WAS LEAKING. STOPPED INFUSION, CHECKED LINES, SPIROS APPEARED TO BE LEAKING. CONTACTED PHARMACY, (INSTRUCTED) TO DISCONNECT AND A NEW BAG WOULD BE MADE. PHARMACY BOUGHT UP NEW BAG AND TUBING¿" INFUSION/THERAPY RESUMED. NO REPORTED ADVERSE PATIENT/OPERATOR CONSEQUENCES/EXPOSURES. MANUFACTURER'S INVESTIGATION: LOT RECORD ANALYSIS: A REVIEW OF THE MFG LOT DATABASE FOR LOT# 1781492 (MFG DATE 11/2009) SHOWS (B)(4). ALTHOUGH THE EXACT CAUSE OF THE REPORTED EVENT IS UNK, ADDITIONAL ENGINEERING INVESTIGATIONS WERE CONDUCTED. THE ENGINEERING TESTS RECORDED MIXED RESULTS HOWEVER, THE PROBLEM WAS REPLICATED IN STATISTICALLY SMALL QUANTITIES OF IN-HOUSE TEST SAMPLES WHERE COMPONENT DAMAGES OCCURRED WHEN OVERTIGHTENED. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE LEAKAGE/PERFORMANCE ISSUES. SEVERAL PROCESSING/EQUIPMENT IMPROVEMENTS HAVE BEEN IDENTIFIED, EVALUATED AND ARE IN VARIOUS STAGES OF QUALIFICATION AND IMPLEMENTATION, INCLUDING: (B)(4). SPIROS PERFORMANCE SPECIFICATIONS HAVE BEEN MODIFIED TO INCLUDE HEIGHTENED AND EXPANDED COMPONENT LEAK TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIROS CONNECTOR CLOSED MALE CONNECTOR FPA ICU MEDICAL, INC. CH2000 1781492

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR NI - MFR, MAKE & MODEL OF INVOLVED MATING DEVICES