BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 3250811 · Received July 29, 2013

    Report

    Report Number
    2015691-2013-20692
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 4, 2013
    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

    WE RECEIVED ONE SINGLE DPT KIT WITH AN IV SET AND PRESSURE TUBING FOR EXAMINATION. BOTH THE IV AND PRESSURE TUBING REMAINED COILED WITH A PAPER BAND. THE VENTED CAP WAS STILL ATTACHED AT THE DISTAL END OF THE PRESSURE LINE. ONE LOOSE CLEAR-COLOR PARTICULATE WAS FOUND INSIDE OF THE IV TUBE NEAR THE CODAN DRIP CHAMBER. THE PARTICULATE WAS APPROXIMATELY 2 X 2 MM IN SIZE. THE PARTICULATE DID NOT GET FLUSH OUT OF THE KIT DURING 5 MINUTES OF CONTINUOUS FLUSHING. THE PARTICULATE MOVED FROM THE IV TUBING TO THE DPT HOUSING AND GOT STUCK AT FLOW RESTRICTOR AREA. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH THE CHEMISTRY ANALYSIS REPORT AND POSSIBLE CORRECTIVE OR PREVENTATIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    THE IR ANALYSIS SHOWED THAT THE PARTICLE IS MOST PROBABLY MADE OF POLYAMIDE (PA). THE MANUFACTURER OF THE IV TUBING, CODAN, STATED THAT THE NATURE OF THE PARTICLE IS PROBABLY ¿A PARTICLE COMING FROM THE PARTICLE FILTER IN THE DRIP CHAMBER. THIS FILTER IS THE ONLY COMPONENT OF THE SET ABOVE THE POSITION OF THE PARTICLE IN THE SYSTEM, WHICH IS MADE UP OF PA.¿ CODAN FURTHER STATES THAT ¿REVIEW OF THE PRODUCT COMPLAINT HISTORY SHOWS THIS COMPLAINT TO BE THE FIRST ONE DUE TO THIS KIND OF CONTAMINATION.¿ ¿THERE IS EVERY INDICATION THAT IT CONCERNS AN ISOLATED INCIDENT AND THAT THE DANGER OF RECURRENCE IS VERY LOW.¿ THEY ARE NOT TAKING ANY ACTIONS AT THIS TIME AND WILL MONITOR THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "UNKNOWN DUST-LIKE MATERIAL WAS FOUND INSIDE OF THE IV TUBING JUST BELOW THE IV DRIP CHAMBER WHEN THE CUSTOMER WAS PREPARING FOR PRIMING BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354195 CUSTOM DEFINED PRODUCT TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR TC0113S01_ CF1411MT

    Patients

    Seq Age Sex Outcome Treatment
    1