BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2991648 · Received March 6, 2013

    Report

    Report Number
    2015691-2013-19451
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 28, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K924452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THAT THE CATHETER WAS DISCARDED AND NOT ABLE TO BE RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT A PRODUCT RETURN. THERE WERE TWO POSSIBLE LOT NUMBERS REPORTED AND A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    INITIALLY IT WAS REPORTED THAT SHORTLY AFTER THE INSERTION OF THE CATHETER, WITHIN 24 HOURS, THE THERMISTOR ON THE CATHETER 'MALFUNCTIONED.' THERE WERE NO VALUES OBSERVED FROM THE CATHETER. THE STAFF REPLACED THE CATHETERS WITH NEW ONES. ADDITIONAL INFORMATION REVEALED THAT DURING THE EVENT THE CO VALUES DISAPPEARED FROM THE VIGILANCE MONITOR. IT WAS FURTHER INDICATED THAT 'STRANGE/ODD' VALUES WERE OBSERVED FROM OTHER PARAMETERS ON THE VIGILANCE. UNFORTUNATELY DETAILS OF THE DESCRIPTION OF THE INCIDENTS WERE LIMITED, NO OTHER INFORMATION COULD BE PROVIDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95941 SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER WITH AMC THROMBOSHIELD CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 744HF75 59325115 OR 59325118

    Patients

    Seq Age Sex Outcome Treatment
    1