BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3122565 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13028
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS MANIFESTED AS CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE WAS NOT REPORTED. THE PD EFFLUENT CLEARED FOLLOWING TREATMENT WITH INTRAPERITONEAL INJECTION (IP) OF GENTAMYCIN AND IP VANCOMYCIN (DOSES AND FREQUENCIES NOT REPORTED). PATIENT OUTCOME NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225043 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention PHYSIONEAL 40, 2.27%, PHYSIONEAL 40, 1.36%| EXTRANEAL