BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTIQ CCO CATHETER

    MDR report key: 2039426 · Received March 21, 2011

    Report

    Report Number
    2025816-2010-00124
    Event Type
    Other
    Date Received
    March 21, 2011
    Date of Event
    August 27, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR FOLLOW-UP INFO HAVE BEEN UNSUCCESSFUL. THE DEVICES WERE SUCCESSFULLY PRE-TESTED WITH NO PROBLEMS NOTED. THE ACTUAL CATHETERS INVOLVED IN THE REPORTED EVENTS WERE DISCARDED AND OR ARE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS AND INVESTIGATION. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. EXACT CAUSE(S) OF THE REPORTED PROBLEMS ARE UNK. THE MFR'S (B)(4) TO PERFORM INSERVICING WITH STAFF TO REVIEW DEVICE USAGE, TECHNIQUES.

    Description of Event or Problem · 1

    (B)(4) REC'D. REPORTING MULTIPLE PROBLEMS (ERRONEOUS, ERRATIC READINGS, BALLOON INFLATION) AND CONCERNS WITH USE OF EST. QTY. OF TWELVE (12) 52511-13 OPTIQ CATHETERS. THE STATES "THE PT'S CLINICAL PICTURE DOES NOT CORRELATE WITH THE MONITORING VALUES GENERATED BY THIS DEVICE. THIS REPORT IS REFLECTIVE OF INFORMATION CONCERNING THE CARE OF (B)(6) DIFFERENT PATIENTS. IN SUMMARY, THE PROBLEMS PRESENTED WITH THIS DEVICE INCLUDE THE FOLLOWING: FREQUENTLY PLACES DOUBT IN RELIABILITY OF CARDIAC OUTPUT AND PULMONARY ARTERY (PA) NUMBERS. DOES NOT CORRELATE WITH CLINICAL PICTURE I.E. BP ASSESSMENT, ETC. CARDIAC OUTPUT (C.O.) = 1.0 AND PT ALERT AND ORIENTED. THE ABOVE OCCURS DESPITE THE COMPLETED BRIDGE VERIFICATION. THERE ARE BROAD VARIATIONS OF CARDIAC OUTPUT AND INDEX VALUES WITHIN A BRIEF PERIOD OF TIME, I.E. CARDIAC OUTPUT 2.4 THAN 10.2 WITHIN A FEW MINUTES. UNABLE TO TRUST VALUES TO TITRATE ADMINISTRATION OF VASOACTIVE MEDICATIONS. CLINICIANS HAVE REPORTED "THE INABILITY TO OBTAIN PROPER WAVEFORMS WITH MANIPULATION OF THE CATHETER AND IN ONE CASE HAD TO DISCONTINUE THE CATHETER WITHIN FOUR HOURS OF SURGERY." ON ONE INSTANCE, THE CATHETER BALLOON RUPTURED AT TIME OF INSERTION REQUIRING THE USE OF A SECOND CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIQ CCO CATHETER CATHETER FPA ICU MEDICAL, INC. 52511-13 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR WARMING DEVICES NOI| SEQUENTIAL COMPRESSION DEVICE (SCD)