BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2072796 · Received April 29, 2011

    Report

    Report Number
    2015691-2011-15358
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 15, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    KRA
    PMA / PMN Number
    K924661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL NUMBER WAS PROVIDED. FOLLOW UP WITH CUSTOMER INDICATED THAT THE HOSPITAL HAS NOT HAD THIS TYPE OF EVENT OCCUR SINCE THE REPORTED COMPLAINT. THE ISSUE WAS RESOLVED AT THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE DEVICE WE ARE UNABLE TO CONFIRM THE COMPLAINT OR DETERMINE POTENTIAL CONTRIBUTING FACTORS. NO ACTIONS WILL BE TAKEN AT THIS TIME. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THERE WAS "DEFAULTED CATHETERS" AT THE HOSPITAL. ADDITIONAL INFORMATION INDICATED THAT TEMPERATURE OF THE CATHETER WAS DIFFERENT THAN WHAT WAS READING ON THE TEMPERATURE PROBE. THERE WERE NO PATIENT COMPLICATIONS. THE LOT AND MODEL NUMBERS COULD NOT BE PROVIDED BY THE CUSTOMER. IT WAS INDICATED THAT IT WAS A CCO CATHETER AND A VIG II MONITOR AND THAT TROUBLESHOOTING MAY HAVE BEEN PERFORMED. AT THE TIME OF THE REPORT, THE ISSUE HAD BEEN RESOLVED. THE CATHETER WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD CONTINOUS CARDIAC OUPTUT CATHETER KRA EDWARDS LIFESCIENCES, PR CCOCATHUNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1