BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA POWER INJECTABLE

    MDR report key: 1380363 · Received February 27, 2009

    Report

    Report Number
    2032582-2009-00002
    Event Type
    Malfunction
    Date Received
    February 27, 2009
    Date of Event
    November 5, 2008
    Report Date
    February 25, 2009
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVAL. DEVICE HISTORY RECORD REVIEW: NO NON-CONFORMANCE'S ASSOCIATED WITH LOT NO: 0823CS LABELING REVIEW. IFU L1016/A REV .06 .08/1200/ALF. GUIDE FOR NURSING STAFF - L1017/A REV .06 .08/1200/ALF. THE IFU AND GUIDE FOR NURSING STAFF WERE REVIEWED. THE TROUBLESHOOTING GUIDE IN THE GUIDE FOR NURSING STAFF IDENTIFIES SOME POSSIBLE CAUSES FOR PORT FAILURE: FAILURE TO FLUSH ADEQUATELY, RESULTING IN LUMEN OBSTRUCTION. BLOOD CLOT, FIBRIN SHEATH, OR PARTICULAR MATTER OBSTRUCTING THE LUMEN. COMPRESSION OR TRANSACTION OF THE CATHETER BETWEEN THE CLAVICLE AND THE FIRST RIB "PINCH-OFF AREA". KINKED CATHETER. MALPOSITION OF CATHETER TIP (IE, JUGULAR VEIN, OUTSIDE OF VEIN). IMPROPER CATHETER LENGTH SELECTION FOR PT SIZE. WITHOUT THE ACTUAL SAMPLE AVAILABLE FOR EVAL, UNABLE TO DETERMINE CAUSE FOR FAILURE. (B) (4).

    Description of Event or Problem · 1

    FROM USER FACILITY REPORT (B) (4). EVENT DESC: THE PORT HAD BEEN PLACED TWO MONTHS PRIOR TO IT FAILING TO FUNCTION FOR UNK REASONS THIS PAST FALL. THERE WAS NO KNOWN HARM TO PT. DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCELA POWER INJECTABLE IMPLANTED PORT AND CATHETER SYSTEM LJT PFM MEDICAL, INC. H 965451030 0823 CS

    Patients

    Seq Age Sex Outcome Treatment
    1