BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3854147 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18206
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    October 15, 2013
    Report Date
    May 12, 2014
    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). (B)(6). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED THE SAME DAY FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN. ON AN UNSPECIFIED DATE (DURING THE SAME MONTH OF PERITONITIS ONSET) THE PATIENT WAS TREATED WITH UNSPECIFIED INTRAVENOUS (IV) ANTIBIOTICS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT (ON AN UNREPORTED DATE DURING THE SAME MONTH OF PERITONITIS ONSET). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331571 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R HOMECHOICE| DIANEAL 1.5%, 2.5% AND 4.25% SOLUTIONS