BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER

    MDR report key: 2871057 · Received December 12, 2012

    Report

    Report Number
    2015691-2012-18831
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED. IT WAS NOT POSSIBLE TO CONFIRM THE COMPLAINT WITHOUT A PRODUCT RETURN. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. WITH SUCH LIMITED INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, THE TEMPERATURE PROVIDED BY THE CATHETER WERE NOT CORRELATING WITH THE PATIENT; THE TEMPERATURES WERE OBSERVED TO READ 26 -35C; HOWEVER, THE RECTAL TEMPERATURE INDICATED THAT THE PATIENT WAS FINE. THE CO CABLE PASSED TESTING. NO PATIENT INJURY OCCURRED AND THE PATIENT WAS DISCHARGED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 746F8 59314903

    Patients

    Seq Age Sex Outcome Treatment
    1