BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER W/ AMC THROMBOSHIELD

    MDR report key: 2162840 · Received July 15, 2011

    Report

    Report Number
    2015691-2011-15866
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 14, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURN OF THE PRODUCT, NOR COULD A ROOT CAUSE OR POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT STATED THAT CCO MEASUREMENT WAS INACCURATE DURING USE. THE CATHETER WAS INSERTED AFTER THE INDUCTION OF ANESTHESIA FOR BYPASS SURGERY AND USED WITH A CEDV MONITOR. THE BLOOD PRESSURE WAS DECREASING WHILE BOTH CCO AND STAT CCO READINGS WERE 7L AND THOSE VALUES DID NOT CHANGE. THE CUSTOMER NOTICED THE ABNORMALITY AND SHOT A BOLUS CO MEASUREMENT, WHICH WAS 3.5L. THE CO VALUE WAS ALSO CHECKED BY A DEVICE OF OTHER COMPANY FOR PULSE CO MEASUREMENT AND THE READING WAS ALSO 3.5L. THE CATHETER POSITION WAS REASONED TO BE CORRECT BY THE LENGTH OF CATHETER BODY INSERTED AND CENTRAL VENOUS PRESSURE (CVP) MONITORING. NO MANIPULATION HAD BEEN ADDED TO THE HEART BY THIS STAGE. THE TRANSITION OF CCO VALUES DURING SURGERY WAS NOT REPORTED. NO PROBLEM WAS OBSERVED WITH THE CEDV MONITOR AND 70-CC2 CABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE DEVICE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER W/ AMC THROMBOSHIELD SWAN-GANZ CATHETER DQE EDWARDS LIFESCIENCES, PR 774HF75J UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1