BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIQ CATHETER

    MDR report key: 4092963 · Received September 4, 2014

    Report

    Report Number
    2025816-2014-00103
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: THE INVOLVED 011-52509-12 WAS NOT RETURNED FOR ANALYSIS. SIX (6) PACKAGED 011-52509-12 SAME LOT 2768898 SAMPLES WERE RETURNED. ENGINEERING INVESTIGATION, TESTING AND ANALYSIS: THE RETURNED 011-52509-12 CATHETERS WERE TESTED PER THE APPLICABLE PRODUCT SPECS INCLUDING THERMISTOR ACCURACY TEST, THERMAL COIL CIRCUIT RESISTANCE CHECK. THE RESULTS RECORDED NO OUT OF SPEC CONDITIONS AND OR PERFORMANCE ANOMALIES. LOT BUILD REVIEWS: A REVIEW OF THE MFG LOT BUILD DATABASE FOR THE 011-52509-12 LOT# 2768898 (MFG DATE 11/01/2013) SHOWS (B)(4) UNITS WERE ALL MFG., TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG. LOT BUILDS. FINDINGS: THE INVOLVED 011-52509-12 WAS NOT RETURNED FOR TESTING AND ANALYSIS. ENGINEERING TESTING OF THE SIX RETURNED SAME LOT SAMPLES RECORDED NO PERFORMANCE ISSUES AND/OR PUT OF SPEC CONDITIONS. THE EXACT CAUSE(S) OF THE REPORTED EVENT/PRODUCT ISSUES IS UNK AT THIS TIME. THIS REPORT AND THE ASSOCIATED DATA HAVE BEEN ENTERED IN THE MANUFACTURERS DATABASE AND WILL BE MONITORED AND TRENDED.

    Description of Event or Problem · 1

    INT'L ((B)(6)) COMPLAINT RECEIVED REPORTING ERRONEOUS READINGS WITH USE OF (B)(6) OPTIQ CATHETER. IT WAS REPORTED THAT "...DURING THE OPERATION, MEASURED CCO WAS NOT REALISTIC, IT WAS TOO LOW AND SIGNAL WAS CONTINUOUSLY LOST. THE CLINICAL PICTURE OF THE PT HEMODYNAMIC PARAMETERS WERE NORMAL, SUCH AS HR, MAP (SYSTOLE, DIASTOLE), CVP, SPO2. HB, ETC." MEASUREMENTS WERE DONE BY BOLUS. FOLLOW UP INFO REPORTED "..WHEN THE CATHETER WAS CONNECTED TO THE ANOTHER MONITOR AFTER OPERATION, NORMAL VALUES WERE SHOWED.". THERE WERE NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542171 OPTIQ CATHETER TD CATHETER FPA ICU MEDICAL, INC. 011-52509-12 2768898

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Q2 PLUS MONITOR,| CABLES