BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIROS CONNECTOR

    MDR report key: 1834053 · Received June 1, 2010

    Report

    Report Number
    2025816-2010-00019
    Event Type
    Other
    Date Received
    June 1, 2010
    Date of Event
    January 11, 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 A (B)(6) 2010 CHEMO LEAKAGE INCIDENT WITH ONE (1) CH2000 SPIROS AND ONE (1) CH2000S SPINNING SPIROS CONNECTORS. THE REPORT STATES "IV TUBING CONTAINING IFOSFAMIDE WITH MESNA FOUND TO BE LEAKING AT THE SPIROS CONNECTION. IMMEDIATELY STOPPED INFUSION. REPLACED EXISTING SPIROS (DID NOT SPIN) WITH A NEW SPIROS SPINNER NOTED TO BE FUNCTIONAL. RESUMED INFUSION, IV TUBING STILL LEAKING. REMOVED IV TUBING. CLEANED UP AREA USING CHEMO SPILL KIT. PATIENT NOTED TO HAVE A FEW DROPS OF IV FLUID ON HIS HANDS, PAJAMAS AND BEDDING. PATIENT HAD A SHOWER TO CLEANSE SKIN. DISCARDED LINENS AND CLOTHING IN CHEMO SPILL KIT BAG. PATIENT STABLE, NO EFFECT ON PATIENT. APPROXIMATELY 27 MLS OF IV FLUID LEAKED (20 MLS NS PRIME VOL +7 MLS IFOSFAMIDE WITH MESNA). PHYSICIAN AND PHARMACIST NOTIFIED. NEW INFUSIONS HUNG." MANUFACTURER'S INVESTIGATION: LOT RECORD ANALYSIS: A REVIEW OF THE MFG LOT DATABASE FOR LOT# 1717298 (MFG DATE 08/2009) 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 1717298

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR NI - MFR, MAKE & MODEL OF INVOLVED MATING DEVICES