BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSET SYSTEM

    MDR report key: 4471497 · Received January 30, 2015

    Report

    Report Number
    2015691-2015-00193
    Event Type
    Malfunction
    Date Received
    January 30, 2015
    Date of Event
    December 7, 2014
    Report Date
    January 5, 2015
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRB
    PMA / PMN Number
    K811399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, AT THIS TIME THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT. A SUPPLEMENTAL REPORT WILL BE SENT WITH THE FINAL INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    PER FURTHER FOLLOW UP WITH THE CUSTOMER IT WAS CONFIRMED THAT COSET DEVICE WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION. WITHOUT RETURN OF THE UNIT IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MEDWATCH NUMBER FOR THE RELATED SWAN-GANZ CATHETER IS 2015691-2015-00195 .

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE COSET 510K NUMBER. THE NUMBER LISTED UNDER SUPPLEMENTAL 2015691-2015-00193-2 DOES NOT PERTAIN TO THE COSET DEVICE, IT IS INCORRECT. THE CORRECT 510K NUMBER FOR THE COSET IS LISTED.

    Description of Event or Problem · 1

    AS REPORTED, DURING USE OF A CO-SET DEVICE AND SWAN-GANZ CATHETER, IT WAS NOTED THAT THE CARDIAC OUTPUT VALUES WERE ABNORMAL AND COULD NOT BE TRENDED. THE CLINICIAN REALIZED THAT FLUID WAS LEAKING AROUND THE INTERIOR OF THE SYRINGE PART OF THE SET. THE NURSE NOTED THAT THE VALUES DID NOT CORRELATE WITH A MIXED VENOUS SAMPLE THAT WAS DRAWN CONCURRENTLY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71005 COSET SYSTEM PROBE, THERMODILUTION KRB EDWARDS LIFESCIENCES DR 93610

    Patients

    Seq Age Sex Outcome Treatment
    1