BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMODILUTION CATHETER

    MDR report key: 876755 · Received July 2, 2007

    Report

    Report Number
    2025816-2007-00006
    Event Type
    Malfunction
    Date Received
    July 2, 2007
    Date of Event
    December 5, 2006
    Report Date
    February 7, 2007
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED VIA RECEIPT OF FDA/CDRH USER FACILITY REPORT REPORTING A 2006, INCIDENT INVOLVING ONE (1) 41229-01 THERMODILUTION CATHETER. THE REPORT STATES THAT "THE SENSOR FOR THE THERMODILUTION CATHETER WAS DEFECTIVE." THERE WAS NO REPORTED PT INJURY. THE FACILITY REPORTER WAS UNABLE TO PROVIDED ANY SPECIFIC EVENT DETAILS, INCLUDING THE NATURE OF THE PROBLEM/DEFECT AND THE IDENTITY OF THE CONCOMITANT PRODUCTS/DEVICES. THE USER FACILITY REPORT INDICATES THAT THE INVOLVED DEVICE WAS RETURNED TO THE MFR ON 12/11/06. PER 2/21/07 FOLLOW-UP PHONE CONVERSATION, THE INVOLVED CATHETER APPEARS TO HAVE BEEN RETURNED TO ANOTHER DEVICE MFR. COMPLAINT ANALYSIS: A REVIEW OF THE MFG. LOT (MFG. 7/06) DATABASE RECORDS SHOWS 960 UNITS WERE MFG., TESTED, INSPECTED AND RELEASED. A REVIEW OF THE DEVICE LABELED DIRECTIONS FOR USE (DFU) WAS ALSO PERFORMED. THE DFU INDENTIFIES SPECIFIC PRE-TEST/SET-UP INSTRUCTIONS THAT ARE DESIGNED TO IDENTIFY ANY POTENTIAL PERFORMANCE ISSUES. CAUSE OF THE REPORTED EVENT IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMODILUTION CATHETER CATHETER DYG ICU MEDICAL INC. 41229-01 43-010-SN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR