BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA POWER INJECTABLE PORT

    MDR report key: 1936085 · Received December 13, 2010

    Report

    Report Number
    2032582-2010-00008
    Event Type
    Injury
    Date Received
    December 13, 2010
    Report Date
    December 10, 2010
    Manufacturer
    PFM MEDICAL USA, INC
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A PROBLEM WAS REPORTED TO (B)(6) MEDICAL REGARDING THE XCELA POWER INJECTABLE PORT (LIST # H965451090, LOT NO'S 1027CS, 1030CS, 1008CS). THE PRODUCT IN QUESTION WAS NOT RETURNED TO (B)(6) MEDICAL FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE REPORTED LOTS. THE RECORDS ARE COMPLETE AND IN ORDER. NO NON-CONFORMITIES HAVE BEEN RECORDED FOR THE LOTS IN QUESTION. OUR MANUFACTURING FACILITY CONDUCTED LEAK TESTING ON SAMPLES FROM THE REPORTED LOTS TO VERIFY THE SPECIFICATIONS FOR THE DEVICE (ALL THREE LOTS PASSED). A REVIEW OF THE RISK ANALYSIS AND THE IFU INDICATE THAT THE RISKS ASSOCIATED WITH THIS COMPLAINT ARE IDENTIFIED IN THE RISK ANALYSIS AND ARE LISTED AS POSSIBLE COMPLICATIONS FOR THE DEVICE. SKIN NECROSIS IS TYPICALLY A SIGN OF AN EXTRAVASATION. THE LEAKAGE OF HIGH OSMOLARITY SOLUTIONS OR CHEMOTHERAPY AGENTS CAN RESULT IN SIGNIFICANT TISSUE DESTRUCTION AND CONSIDERABLE COMPLICATIONS. EXTRAVASATIONS AT THE PORT SKIN SITE COULD BE DUE TO A VARIETY OF REASONS SUCH AS: ACCESSING THE PORT AT THE INCORRECT ANGLE, USING TOO HIGH AN INJECTION PRESSURE, FAILURE TO PROPERLY CONNECT THE PORT AND THE CATHETER OR EVEN LEAKAGE FROM THE PORT. HOWEVER, DUE TO THE FACT THAT THE CUSTOMER DID NOT RETURN THE PORT FOR INVESTIGATION OUR MANUFACTURING FACILITY COULD NOT CONCLUDE WHAT THE DEFINITIVE CAUSE WAS FOR THE NECROSIS AT THE SKIN SITE. POSITIONING DIFFICULTIES, NECROSIS PRESSURE, CONNECTION ERROR, PORT LEAK(S), CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CLIENT REPORTED TO (B)(6) MEDICAL ON NOVEMBER 16TH THAT THERE WAS "NECROSIS AT THE SKIN SITE." ADDITIONAL INFORMATION: THE CUSTOMER DID NOT RETURN A PRODUCT SAMPLE FOR EVALUATION, NOR SUPPLY LOT/BATCH NUMBER INFORMATION. HOWEVER, THE CLIENT PERFORMED A SHIP HISTORY AND THE FOLLOWING LOTS WERE IDENTIFIED AS 1027CS, 1030CS AND 1008CS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCELA POWER INJECTABLE PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT PFM MEDICAL USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention