BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXIMETRY/CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 3040564 · Received March 13, 2013

    Report

    Report Number
    2025816-2012-00091
    Event Type
    Other
    Date Received
    March 13, 2013
    Date of Event
    October 12, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DQE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING ONE 52509-13 OPTI Q CATHETER WAS FOUND TO BE "KNOTTED DISTAL TO THE PA COIL". IT WAS REPORTED, "FOLLOWING PT TRANSPORT FROM SURGERY TO MICU, X-RAY WAS TAKEN ON PT AND A KNOT WAS VERIFIED IN CATHETER TIP. KNOT WAS REMOVED BY PA USING A GUIDEWIRE..." THERE WERE NO REPORTED ADVERSE CONSEQUENCES. DURING THE PROCEDURE, THE CATHETER FUNCTIONED AS INTENDED WITH NO ADVERSE IMPACT TO THE PROCEDURE. THE INVOLVED 52509-13 DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS AND INVESTIGATION. A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER/SIMILAR ISSUE DID NOT IDENTIFY ANY ADDITIONAL REPORTS OR INVESTIGATIONS IDENTIFYING A MANUFACTURING DEFECT/NON-CONFORMANCE. EXACT CAUSE OF THE REPORTED INCIDENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106347 OXIMETRY/CONTINUOUS CARDIAC OUTPUT CATHETER OPTIQ SV02/CCO FIBEROPTIC CATHETER DQE ICU MEDICAL, INC. 52509-13 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1