BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX

    MDR report key: 296780 · Received September 14, 2000

    Report

    Report Number
    1717671-2000-00001
    Event Type
    Malfunction
    Date Received
    September 14, 2000
    Date of Event
    July 7, 2000
    Report Date
    September 12, 2000
    Manufacturer
    DENVER BIOMEDICALS, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS USING A PLEURX VACUUM BOTTLE WITH DRAINAGE LINE TO REMOVE EXCESS FLUID FROM THE PLEURAL SPACE. DURING THE DRAINAGE PROCEDURE, THE ACCESS TIP BECAME SEPARATED FROM THE DRAINAGE LINE, BUT NOT FROM THE PLEURAL CATHETER VALVE. THEREFORE, THE INTERIOR OF THE PLEURAL CATHETER WAS TEMPORARILY EXPOSED TO THE ATMOSPHERE. SOON THEREAFTER, THE PT FELT PAIN IN THE CHEST WALL AND REMOVED THE ACCESS TIP FROM THE PLEURAL CATHETER VALVE, WHICH IS AUTOMATICALLY CLOSED IN THE ABSENCE OF THE ACCESS TIP. THE PAIN SUBSIDED OVER THE NEXT DAY. THE REMAINING BOTTLE/DRAINAGE LINE ASSEMBLES IN THE KIT PERFORMED AS EXPECTED AND SUBSEQUENT DRAINAGE PROCEDURES DID NOT CAUSE ANY RECURRENCE OF THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX VACUUM POWERED BODY FLUID SUCTION SYSTEM KDQ DENVER BIOMEDICALS, INC. * 257496

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other