BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFIND PRODUCT

    MDR report key: 2220556 · Received August 23, 2011

    Report

    Report Number
    2015691-2011-16085
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 27, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETE AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    RECEIVED ONE SINGLE DPT-VAMP FLEX KIT WITH ATTACHED INFUSION SET AND PRESSURE TUBING FOR EXAMINATION. PRIMING SOLUTION WAS VISIBLE INSIDE OF THE WHOLE LINE BUT NO BLOOD WAS VISIBLE AT DISTAL END OF THE LINE. THE PRESSURE TRANSDUCER ZEROED AND SENSED PRESSURE ACCURATELY ON A NIHON KOHDEN BEDSIDE MONITOR. PRESSURE WAS MEASURED AT VARIOUS PRESSURE VALUES, 0, 50, 100 AND 300 MMHG AND IN REVERSE ORDER. ELECTRICAL TESTING SHOWED THAT BOTH INPUT AND OUTPUT IMPEDANCE WERE WITHIN SPECIFICATIONS. ZERO-OFFSET ALSO MET SPECIFICATION PER IFU. NO VISIBLE DAMAGE WAS FOUND AT THE CABLE CONNECTOR. VISUAL EXAMINATIONS WERE PERFORMED UNDER 10 X MAGNIFICATIONS. THE REPORTED EVENT OF "PRESSURE MEASUREMENT WAS INACCURATE" COULD NOT BE CONFIRMED. THERE WAS NO EVIDENCE OF A MANUFACTURING DEFECT; NO ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE DEVICE HISTORY DATA IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PRESSURE MEASUREMENT WAS INACCURATE DURING USE. MONITOR WAS SHOWING -5MMHG WHEN THE VALUE WAS EXPECTED TO BE OVER 100MMHG." DURING THE INVESTIGATION, IT WAS DETERMINED THAT NO FAULTS OR ERROR MESSAGES DISPLAYED ON THE MONITOR. THE WAVEFORM WAS NOT NORMAL; IT WAS NOTED THAT THE PRESSURE DID NOT RISE. THE "RA" WAS BEING MONITORED. THE LINE WAS CONFIRMED TO BE PATENT. THE DPT WAS ZEROED AT THE PHLEBOSTATIC AXIS. A SAMPLE OF THE TRACING WAS NOT AVAILABLE FOR REVIEW. THE PROBLEM WAS RESOLVED BY REPLACING THE KIT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM DEFIND PRODUCT DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR VO1706TSPL02 YE0747MT

    Patients

    Seq Age Sex Outcome Treatment
    1