BEUDAMED
    FDA Adverse Event Other Summary report: N

    TDCH THERMODILUTION PA CATHETER

    MDR report key: 2039468 · Received March 21, 2011

    Report

    Report Number
    2025816-2011-00001
    Event Type
    Other
    Date Received
    March 21, 2011
    Date of Event
    November 18, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT ANALYSIS: THE THERMISTOR IS A PURCHASED COMPONENT. SUPPLIER QUALITY MGMT. WAS NOTIFIED OF THESE FINDINGS FOR THEIR REVIEW AND FOLLOW UP INFO. CONCLUSION: THE ROOT CAUSE OF THE REPORTED PRODUCT EXPERIENCE CANNOT BE DETERMINED WITH ABSOLUTE CERTAINTY. THE MFR IS MONITORING AND TRENDING FOR ANY REPEAT OCCURRENCES.

    Description of Event or Problem · 1

    UFMW REC'D REPORTING READING ERRORS WITH ONE 41232-01 THERMODILUTION PA CATHETER. IT WAS REPORTED "THE SWAN GANZ CATHETER WAS FINE YESTERDAY AND LAST NIGHT WHEN I HAD THE PT. HOWEVER, THIS MORNING I COULDN'T DO A CARDIAC OUTPUT AND THOUGHT IT WAS THE THERMISTOR. I CHANGED CABLES, THREE DIFFERENT ONES, AND AT ONE POINT DID GET A CARDIAC OUTPUT AND CARDIAC INDEX, BUT THE WAVEFORM NEVER RETURNED TO BASELINE." THE CATHETER WAS PRE-TESTED, INSERTED AND SUCCESSFULLY USED FOR 24 HOURS WITH NO PROBLEMS NOTED. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. RECORD REVIEW: A REVIEW OF THE MFG LOT DATABASE FOR LOT # 80-670-LA (MFG DATE 09/2009) SHOWS (B)(4) UNITS WERE MFG. THE 41232-01 CATHETER WAS RETURNED TO THE MFR FOR ANALYSIS AND INVESTIGATION. VISUAL ANALYSIS OF THE RETURNED 41232-01 CATHETER RECORDED NO VISIBLE ANOMALIES. FUNCTIONAL TESTS WERE PERFORMED. THE ENGINEERING REPORT DOCUMENTED INTERMITTENT READINGS WERE REPLICATED WHEN MANIPULATING THE DEVICE THERMISTOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDCH THERMODILUTION PA CATHETER PA CATHETER FOZ ICU MEDICAL, INC. 41232-01 80-670-LA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR CABLES| UNKNOWN: MANUFACTURER/MAKE/MODEL| UNKNOWN: CARDIAC OUTPUT COMPUTER