BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4812182 · Received June 2, 2015

    Report

    Report Number
    1416980-2015-23669
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 11, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON THE SAME DAY AS THE EVENT ONSET, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT DETAILS WERE NOT REPORTED. ON AN UNKNOWN DATE, DIANEAL AND EXTRANEAL THERAPIES WERE DISCONTINUED (CURRENT MODE OF DIALYSIS NOT REPORTED). AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND IS RECOVERING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357085 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization DIANEAL 2.5% AMBUFLEX,| DIANEAL 1.5% AMBUFLEX, EXTRANEAL VIAFLEX