BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA POWER INJECTABLE PORTS

    MDR report key: 1623987 · Received February 25, 2010

    Report

    Report Number
    2032582-2010-00002
    Event Type
    Malfunction
    Date Received
    February 25, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 25, 2010
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PFM MEDICAL HAS MADE MULTIPLE ATTEMPTS TO RETRIEVE ADDITIONAL PATIENT INFORMATION WITH NO SUCCESS. CONCLUSION: THE REVIEW OF THE DEVICE HISTORY RECORDS AND THE INVESTIGATION OF THE RETURNED PORT SHOWED NO NON-CONFORMITIES. WE DON'T KNOW THE EXACT OF THE CAUSE OF THE REPORTED FAILURE. WITHOUT DEFINITIVE CAUSE OF SUCH DEFECT, A CORRECTIVE OR PREVENTIVE ACTION WILL NOT BE OPENED. CPP WILL CONTINUE MONITORING FOR ADDITIONAL OCCURRENCES OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PORT AND CATHETER WERE IN PLACE, THE SYSTEM COULD NOT INFUSE OR ASPIRATE. PROCEDURE WAS COMPLETED WITH A DIFFERENT BUT SIMILAR DEVICE. PATIENT CONDITION NOTES: PATIENT IS OK. PROBLEM NOTICED: DURING PROCEDURE. TREATMENT OR DIAGNOSIS: TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCELA POWER INJECTABLE PORTS IMPLANTED PORT AND CATHETER SYSTEM LJT PFM MEDICAL, INC 0932CS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention