BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3131904 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13513
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE EXACT AGE AT THE TIME OF THE EVENT IS UNKNOWN. THE EXACT DATE OF THE EVENT IS UNKNOWN. HOWEVER, THE PATIENT EXPERIENCED PERITONITIS IN (B)(6) 2012.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL AND EXTRANEAL AT THE TIME OF THE EVENT WAS NOT REPORTED. PD THERAPY WAS DISCONTINUED. THE PATIENT EXPERIENCED BACTERIAL PERITONITIS WHICH DID NOT REQUIRE HOSPITALIZATION. DIAGNOSTIC AND TREATMENT INFORMATION WAS NOT PROVIDED. THE PATIENT WAS GIVEN UNSPECIFIED ANTIBIOTICS, WHICH CONTINUED FOR A MONTH. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237327 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTRANEAL 2.5L| DIANEAL PD4 5L 1.5%, DIANEAL PD4 5L 2.5%