BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3840846 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17414
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BACTERIAL PERITONITIS MANIFESTED BY NAUSEA AND ABDOMINAL PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR LONG TERM CARE FOR AN UNRELATED INDICATION. HOSPITALIZATION IS ONGOING. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE ONSET OF THE PERITONITIS, THE PATIENT BEGAN TREATMENT WITH ANCEF 2G DAILY AND CEPHRADINE 2G DAILY FOR THE PERITONITIS EVENT (ROUTE OF ADMINISTRATION AND DURATION NOT REPORTED). TREATMENT FOR THE PERITONITIS WAS REPORTED AS ONGOING. RECOVERY FROM THE PERITONITIS EVENT WAS ONGOING. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318493 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention HOMECHOICE| DIANEAL 1.5% AND 2.5% PD4, EXTRANEAL 7.5%