BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 2832391 · Received November 14, 2012

    Report

    Report Number
    2015691-2012-18650
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND A VISUAL ANALYSIS WAS PERFORMED. WE RECEIVED ONE SINGLE CDP DPT - VAMP PLUS KIT. THE KIT INCLUDED THE IV SPIKE THAT COMES WITHOUT A DRIP CHAMBER OR INTERNAL FILTER (INSIDE THE DRIP CHAMBER). PRIMING SOLUTION WAS VISIBLE INSIDE OF THE KIT. THE PRESSURE TUBING REMAINED COILED WITH A PAPER BAND. THE VENTED CAP WAS STILL ATTACHED TO THE END OF PRESSURE LINE. THERE WAS NO VISIBLE BLOOD WAS FOUND AT THE DISTAL TUBING MALE CONNECTOR. ONE LOOSE BLACK PARTICULATE WAS FOUND IN THE SOLUTION INSIDE OF THE PRESSURE TUBING OF THE VAMP PLUS UNIT, WHICH CONNECTS TO THE ZERO-STOPCOCK OF THE DPT. THE KIT WAS FLUSHED AT A PRESSURE OF 350 MMHG FOR 5 MINUTES. PRIMING SOLUTION WAS COLLECTED AND FILTERED THROUGH A FILTER PAPER. THE PARTICULATE WAS FLUSHED OUT TO THE FILTER PAPER AND COLLECTED FOR CHEMISTRY ANALYSIS. THE PARTICULATE APPEARED BLACK IN COLOR AND WAS APPROXIMATELY 0.02" LONG. VISUAL EXAMINATIONS WERE PERFORMED AT 10X MAGNIFICATION . PER CHEMISTRY ANALYSIS, THE IR SPECTRUM OF THE DUST-LIKE PARTICULATE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO CELLOPHANE-LIKE MATERIAL. THE COMPLAINT WAS CONFIRMED BUT HAS NOT YET BEEN CONCLUSIVELY RELATED TO THE MANUFACTURING PROCESS, AS THE PRODUCT WAS RETURNED AFTER IT HAD BEEN HANDLED AND PRIMED. AN INVESTIGATION HAS BEEN OPENED TO REVIEW THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN DUST-LIKE MATERIAL WAS FOUND INSIDE THE TUBING WHILE IT WAS BEING PRIMED. THE KIT WAS NOT USED AND NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM DEFINED PRODUCT TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR VP1012TS03(PL)_ ZL0168MT

    Patients

    Seq Age Sex Outcome Treatment
    1