BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDP UNKNOWN

    MDR report key: 2081679 · Received May 9, 2011

    Report

    Report Number
    2015691-2011-15494
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE TRIPLE DPT-VAMP FLEX KIT WITH ATTACHED INFUSION SET AND PRESSURE TUBING SET FOR EXAMINATION. ALL PRESSURE TUBINGS REMAINED COILED WITH BAND PAPER. PRIMING SOLUTION WAS VISIBLE INSIDE OF THE WHOLE LINE. THE COMPLAINT OF "UNKNOWN WHITE MATERIAL WAS OBSERVED INSIDE OF VAMP FLEX" WAS CONFIRMED. AN UNKNOWN WHITE PARTICLE WAS VISIBLE AT THE SURFACE OF THE VAMP FLEX PISTON. THE SIZE OF THE PARTICLE COULD NOT BE MEASURED SINCE THE PARTICLE WAS LOCATED ON THE PISTON. VISUAL EXAMINATIONS WERE PERFORMED UNDER 10X MAGNIFICATION. THE PARTICULATE WAS ON THE TOP SURFACE OF THE BLACK PISTON OF THE VAMP FLEX SYSTEM. THE PARTICULATE SHOULD NOT FLUSH OUT OF THE KIT DURING PRIMING OR FLUSHING BECAUSE THE VAMP SYSTEM IS OFF LINE; HOWEVER, THE PARTICULATE COULD FLUSH OUT OF THE SYSTEM WHEN BLOOD WAS RETURNED TO THE PATIENT. THE VAMP FLEX WAS ASPIRATED AND INJECTED WITH WATER (TO SIMULATE BLOOD SAMPLING AND RETURNING DURING USE) AT RATE 1CC/SECOND AS RECOMMENDED BY IFU. THE PARTICULATE DID NOT FLUSH OUT OF THE SYSTEM DURING 10 CYCLES OF ASPIRATION AND INJECTION. THE PARTICULATE WAS COLLECTED AND SENT TO CHEMISTRY FOR ANALYSIS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE RESULTS ARE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETE AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    PER CHEMISTRY ANALYSIS, THE IR SPECTRUM OF THE UNKNOWN PARTICULATE MATTER SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARED TO ACRYLONITRILE BUTADIENE STYRENE LIKE MATERIAL. THE MATERIAL WHICH WAS FOUND INSIDE THE COMPONENTS/PARTS COULD HAVE COME FROM THE IN-COMING SUPPLIED PARTS. THIS CONTAMINATION WAS NOT DETECTED DURING 100% INSPECTION; HOWEVER, ALL RELATED OPERATORS AND QUALITY COMPLIANCE INSPECTORS WILL BE RE-TRAINED FOR THE INSPECTIONS THROUGHOUT THE PRODUCTS WHICH INCLUDE THE OUTSIDE AND VISIBLE PARTS INSIDE OF THE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "UNKNOWN WHITE MATERIAL WAS OBSERVED INSIDE THE OFF LINE RESERVOIR OF VAMP FLEX DURING SETUP." THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDP UNKNOWN DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR UNKNOWN XS0128MT

    Patients

    Seq Age Sex Outcome Treatment
    1