BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIROS CONNECTOR

    MDR report key: 1810666 · Received July 27, 2010

    Report

    Report Number
    2025816-2010-00078
    Event Type
    Other
    Date Received
    July 27, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 16, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT CAUSE(S) OF THIS SPECIFIC EVENT ARE UNKNOWN, ICU MEDICAL IS CONTINUING TO INVESTIGATE AND MONITOR DEVICE PERFORMANCE TO ENSURE CORRECTIVE ACTIONS ADDRESS LEAKAGE/PERFORMANCE ISSUES. 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 FDA/MAUDE FOI REPORTING LEAKAGE INCIDENTS INVOLVING CH2000 SPIROS CONNECTORS. THE REPORT DOCUMENTS ONE INCIDENT WHERE "PATIENT WAS IN THE CANCER CENTER TO HAVE CHEMOTHERAPY. THE PATIENT HAD AN IV STARTED WITH A SPIROS ADAPTER ATTACHED. WHILE THE NSS WAS INFUSING, IT WAS NOTED THAT THE ADAPTER WAS LEAKING. THIS WAS NOT THE FIRST ONE NOTED TO BE DOING THIS." THE MAUDE REPORT DID NOT PROVIDE ANY ADDITIONAL INCIDENT INFORMATION, IDENTITY OF THE MATING IV SET NOR WAS THE REPORTING FACILITY/CONTACTS IDENTIFIED. STATUS OF THE INVOLVED DEVICES IS ALSO UNKNOWN. MANUFACTURER'S ANALYSIS: A REVIEW OF THE MFG LOT DATABASE FOR THE REPORTED LOT# 1802350 (MFG DATE 12/2009) SHOWS (B)(4) UNITS WERE MFG, TESTED, INSPECTED AND RELEASED. A SEARCH OF THE COMPLAINT DATABASE FOR THIS LIST#/PROBLEM DID IDENTIFY ADDITIONAL REPORTS. THE INVESTIGATIONS ASSOCIATED WITH THOSE REPORTS RECORDED MIXED RESULTS. ADDITIONAL ENGINEERING STUDIES WERE INITIATED. THE RESULTS OF THOSE STUDIES DOCUMENT COMPONENT LEAKAGES WERE 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 CONNECTOR FPA ICU MEDICAL, INC. CH2000 1802350

    Patients

    Seq Age Sex Outcome Treatment
    1 IV MATING DEVICES - NOI - MFR,| MAKE MODEL UNKNOWN