BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS

    MDR report key: 407681 · Received July 24, 2002

    Report

    Report Number
    MW1025671
    Event Type
    Malfunction
    Date Received
    July 24, 2002
    Date of Event
    July 9, 2002
    Report Date
    July 24, 2002
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SURGERY FOR CABGX1 AND AORTIC VALVE REPLACEMENT. SWAN-GANZ PULMONARY ARTERY CATHETER INSERTED IN OR AND ATTACHED TO CCO MONITOR. MONITOR READ "THERMAL FILAMENT UNAVAILABLE, USE BOLUS MODE". CCO MONITOR AND SVO2 CABLES SWITCHED, BUT SAME MESSAGE APPEARED. NEW PA CATHETER INSERTED AND REMAINDER OF SURGICAL MONITORING WAS UNEVENTFUL. TWO HRS POST-OPERATIVELY IN THE ICU NURSE WAS UNABLE TO OBTAIN A CO OR CI READINGS. THE FAULT ALARM READ, "CHECK THERMISDOR CONNECTION". ALL CONNECTIONS WERE CHECKED AND THE CCO MONITOR WAS RESTARTED. IT FUNCTIONED PROPERLY FOR A SHORT TIME, BUT ALARMED "SIGNAL LOST". A CHECK OF ALL CONNECTIONS WAS DONE AGAIN AND THE CCO MACHINE WAS RESTARTED. CO AND CI READINGS WERE INTERMITTENT FOR THE REST OF THE EVENING SHIFT. NIGHTS ALSO HAD PROBLEMS AND CHANGED THE CCO MACHINE AND ALL CABLES. THE SYSTEM THEN FUNCTIONED WELL FOR ABOUT 8 HRS. A TOTAL OF 2 PA CATHETERS, 3 CCO MACHINES AND SEVERAL SETS OF CABLES WERE USED IN A 16-HR PERIOD. THERE WAS NO ADVERSE OUTCOME TO THE PT. POST OP COURSE WAS UNEVENTFUL WITH RAPID RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SWAN-GANZ -PULMONARY ARTERY- CATHETER DYG EDWARDS LIFESCIENCES LLC * 152DC855

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 5) PRIMACOR IV| 7) ESMOLOL IV| 1) VENTILATOR,| 6) VASOPRESSIN IV| 2) 2 ARTERIAL LINES -ONE RADIAL, ONE FEMORAL,| 8) RANITIDINE IV| 4) ONE PERIPHERAL IV| 3) 2 CHEST TUBES TO PLEUREVAC.| 9) NITROGLYCERINE IV.