BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2015691-2010-14055

    MDR report key: 1834385 · Received September 15, 2010

    Report

    Report Number
    2015691-2010-14055
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    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

    EVALUATION SUMMARY: CUSTOMER REPORT WAS CONFIRMED. REC'D (1) SINGLE DPT KIT. BLACK MATERIALS WERE FOUND INSIDE PRESSURE TUBING (2.5MM X 1.5MM IN SIZE), DPT FLUID PATH (2.5MM X 1 MM IN SIZE) AND BOTTOM OF THE POPPET (3MM LONG). THE GEL ON SENSOR PAD WAS FOUND TO BE DAMAGED AND DISLODGED (SEE ATTACHED PHOTO). DAMAGED GEL DID NOT MOVE DURING PRIMING (UNDER 250MMHG PRESSURE). PRESSURE TUBING WAS ATTACHED TO IV SIDE FO THE KIT, OPPOSITE SIDE COMPARED WITH ITS DRAWING. DPT ZEROED AND SENSED PRESSURE ACCURATELY. ELECTRICAL TESTING SHOWED THAT BOTH INPUT IMPEDANCE (2360OHMS) AND OUTPUT IMPEDANCE (302OHMS) WERE WITHIN SPECIFICATIONS. ZERO-OFFSET (0MMHG) ALSO MET SPECIFICATION PER DFU(VEX = 6.000V AND VO = -0.000003V, SPEC. IS EQUAL OR LESS THAN 25MMHG). GEL PAD WAS DAMAGED BUT DPT FUNCTIONED PROPERLY. (B)(6)2010 (B)(6) LAB: THE BLACK GEL PARTICULATE WAS FOUND INSIDE THE TUBING THAT WAS ATTACHED TO IV SIDE OF THE DPT. THE GEL PARTICULATE WAS 48CM PROXIMAL FROM ITS ORIGINAL LOCATION. SAMPLE WAS SENT TO CHEMISTRY FOR ANALYSIS. ON 9/14/10 PER CHEMISTRY ANALYSIS, (B)(4), THE IR SPECTRUM OF UNKNOWN BLACK SUBSTANCE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO SILICONE LIKE MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "UNKNOWN BLACK MATERIAL WAS OBSERVED INSIDE THE LINE DURING PRIMING." NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXO EDWARDS LIFESCIENCES DR CDPUNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1