BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3180272 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-15997
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, REMEDIAL TREATMENT WITH AN INJECTION OF REFLIN 1 GRAM DAILY (ROUTE NOT REPORTED) AND AN INJECTION OF TOBRAMYCIN 40 MG DAILY (ROUTE NOT REPORTED) WAS INITIATED FOR THE PERITONITIS. THE PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280382 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R DIANEAL PD-2 ULTRABAG 2.5%