BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDP UNKNOWN

    MDR report key: 2081626 · Received May 9, 2011

    Report

    Report Number
    2015691-2011-15466
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE SINGLE DPT KIT WITH ATTACHED INFUSION SET AND PRESSURE TUBING. BOTH THE INFUSION SET AND THE PRESSURE TUBING REMAINED COILED WITH BAND PAPER. NO PRIMING SOLUTION WAS VISIBLE INSIDE OF THE INFUSION SET; HOWEVER, PRIMING SOLUTION WAS VISIBLE INSIDE OF MIDDLE OF THE PRESSURE TUBING. THE COMPLAINT OF "UNKNOWN MATERIAL WAS OBSERVED IN THE ZERO STOPCOCK" WAS CONFIRMED. AN UNKNOWN WHITE CURLED PARTICULATE WAS VISIBLE INSIDE OF THE STOPCOCK FEMALE LUER, WHICH IS LOCATED AT THE DISTAL END OF THE KIT. THE LENGTH OF THE PARTICULATE WAS NOT MEASURED SINCE IT WAS CURLED AND COULD NOT BE MEASURED ACCURATELY. VISUAL EXAMINATIONS WERE PERFORMED UNDER 10X MAGNIFICATION. THE KIT WAS FLUSHED WITH WATER FROM THE IV SIDE AT 350MMHG OF PRESSURE FOR 5 MINUTES. THE PARTICULATE DID NOT MOVE OR GET FLUSHED OUT OF THE KIT. THE PARTICULATE WAS 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 POLYVINYL ACETATE ETHYLENE 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 MATERIAL WAS OBSERVED IN THE ZERO STOPCOCK DURING SETUP." THE SALES REP COMMENTED THAT A SYRINGE IS USED FOR PRIMING IN THE OPERATING ROOM OF THIS HOSPITAL, AS THEY DO NOT USE A PRESSURE BAG DURING THE OPERATION, AND THAT THERE WAS A POSSIBILITY THAT THE UNKNOWN MATERIAL HAD ORIGINATED FROM THE SYRINGE OR THE SALINE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDP UNKNOWN DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR UNKNOWN UX0970MT

    Patients

    Seq Age Sex Outcome Treatment
    1