BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3013778 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06775
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 16, 2013
    Report Date
    March 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO EXPERIENCED PERITONITIS, DURING THERAPY FOR PERITONEAL DIALYSIS (PD). THE PATIENT WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS, ONE DAY AFTER EXPERIENCING DIARRHEA. THE HP WAS DISCHARGED FROM THE HOSPITAL THREE DAYS LATER AND WAS GIVEN UNSPECIFIED ANTIBIOTICS. THE ANTIBIOTICS WERE TAKEN AT HOME, FOR 10 DAYS. TWO WEEKS AFTER LEAVING THE HOSPITAL THE PATIENT WAS STILL RECOVERING FROM THE PERITONITIS AND WAS PUT BACK ON UNSPECIFIED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116052 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R DIANEAL 2.5% AND HOME CHOICE