BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3251584 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19993
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 4, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) EXPERIENCED CHEMICAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY MANIFESTED BY CLOUDY EFFLUENT. THE CAUSE OF PERITONITIS WAS NOT REPORTED. AT THE TIME WHEN EXTRANEAL THERAPY WAS DISCONTINUED AND THE PERITONITIS EVENT WAS RESOLVED. HOWEVER, WHEN THE EXTRANEAL THERAPY WAS INTRODUCED AGAIN, THE CLOUDY EFFLUENT REAPPEARED. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS AND THE EXTRANEAL THERAPY WAS DISCONTINUED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354018 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTRANEAL, DIANEAL PD4 1.36% AND NUTRINEAL.