BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOCLAVE CONNECTOR

    MDR report key: 3566416 · Received November 22, 2013

    Report

    Report Number
    2025816-2013-00141
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 25, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION: A REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER / SIMILAR PROBLEM DID NOT RECORD ANY ADDITIONAL REPORTS/INVESTIGATIONS IDENTIFYING A MFG OR DESIGN RELATED NON-CONFORMANCE. THE INVOLVED DEVICE(S) WERE NOT RETURNED FOR ANALYSIS AND INVESTIGATION. THE CAUSE OF THE REPORTED INCIDENT/PRODUCT ISSUE IS UNK. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER/SIMILAR PROBLEM DID NOT RECORD ANY ADD'L REPORTS/INVESTIGATIONS IDENTIFYING A MFG OR DESIGN RELATED NON-CONFORMANCE. THE MFR COMPLAINT TEAM REVIEWED THE REPORTED INCIDENT/PRODUCT ISSUES. MONTHLY MANAGEMENT REVIEW OF IN-PROCESS ASSEMBLY/QUALITY TREND REPORTS IDENTIFIED NO ADVERSE TRENDS OR CONTRIBUTING ISSUES FOR THE APPLICABLE COMPONENTS/SUB ASSY BUILDS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING MULTIPLE ISSUES WITH USE OF A1000 NANOCLAVE CONNECTOR AND UMBILICAL VENOUS CATHETER/ECMO SET-UP. THE REPORT STATES "..PT WITH MED LINE AND HEPARIN FLUSH TO 2ND PORT OF UVC. NOTED AIR IN MED TUBING AND FLUID AT SYRINGE CONNECTION - ON INSPECTION OF NANOCLAVE, FOUND MEMBRANE NOT POPPING UP FLUSH WITH TOP OF PLASTIC ALLOWING AIR IN EMO CIRCUIT TO ENTER/FLUID TO LEAK OUT.." THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. ALTHOUGH REQUESTED, RELEVANT USAGE/SET-UP AND DEVICE RETURN STATUS HAVE TO DATE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610466 NANOCLAVE CONNECTOR CLAVE CONNECTOR FPA ICU MEDICAL, INC. A1000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SYRINGE| UNK UMBILICAL VENOUS CATHETER