BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3092676 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11277
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS AND TUNNEL INFECTION IN A PATIENT COINCIDENT WITH DIANEAL THERAPY, FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPY WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT WAS DIAGNOSED WITH AND HOSPITALIZED FOR PERITONITIS AND TUNNEL INFECTION. ON AN UNREPORTED DATE, THE PATIENT'S CATHETER WAS REMOVED DUE TO PERITONITIS AND TUNNEL INFECTION. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS AND TUNNEL INFECTION AND WAS PLACED ON A NEW CATHETER AFTER 4 DAYS. THE CONSUMER STATED THAT INFECTIONS HAVE BEEN ONGOING FOR ABOUT A YEAR AND THE PATIENT HAS HAD PREVIOUS CATHETER REMOVALS, BUT THE INFECTION KEEPS COMING BACK. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194155 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 2.5%