BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3183015 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16185
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 29, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS AND LOW HEMOGLOBIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE EVENT FOR 10 DAYS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH CEFAZOLIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR THE PERITONITIS. TREATMENT FOR LOW HEMOGLOBIN WAS NOT REPORTED. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283647 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R DIANEAL PD4 2.5%, DIANEAL PD4 4.25% AND EXTRANEAL