BEUDAMED
    FDA Adverse Event Other Summary report: N

    TDC PA CATHETER

    MDR report key: 2411043 · Received December 22, 2011

    Report

    Report Number
    2025816-2011-00087
    Event Type
    Other
    Date Received
    December 22, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE INVOLVED DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS AND INVESTIGATION. ANALYSIS: A REVIEW OF THE MFG. LOT DATABASE RECORDS FOR LOT NUMBER 91-145-R5 (MFG. DATE (B)(4) 2010) SHOWS (B)(4) UNITS WERE MFG. TESTED, INSPECTED, AND RELEASED. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST/LOT NUMBER AND SIMILAR PROBLEM RECORDED NO ADDITIONAL REPORTS. CONCLUSION: THE EXACT CAUSE OF THE REPORTED PROBLEM REMAINS UNKNOWN. THE INVOLVED 41239-05 PA CATHETER WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AND CONFIRMATION.

    Description of Event or Problem · 1

    (B)(4) RECEIVED REPORTING READING ISSUES WITH USE OF ONE (1) 41239-05 CATHETER. THE (B)(4) DESCRIBES A (B)(6) INCIDENT WHERE "DURING DIAGNOSTIC RIGHT HEART CATHETERIZATION, THE THERMODILUTION RESULTS WERE INCONSISTENT, RESULTING IN INACCURATE CARDIAC OUTPUTS... PATIENT'S HEART RATE WAS REGULAR. READINGS WERE 3.11, 3.76, 4.93, 2.5, 2.03, 2.22 - IN THAT ORDER... NO HARM OCCURRED TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDC PA CATHETER PA CATHETER DYG ICU MEDICAL, INC. 41239-05 91-145-R5

    Patients

    Seq Age Sex Outcome Treatment
    1 MONITOR| CABLES NOI