BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3172721 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15540
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 24, 2013
    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). THE OCCURRENCE DATE WAS UNKNOWN, HOWEVER, IT WAS REPORTED THE EVENT TOOK PLACE AROUND 4 YEARS AGO. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONEAL ENCAPSULATING PERITONEAL SCLEROSIS SYNDROME IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE DRUGS WERE WITHDRAWN. THE PATIENT EXPERIENCED A FEELING LIKE STOMACH BLOCKAGE AND PERITONEUM WAS BREAKING DOWN. THE PATIENT HAD SCARS IN THE INTESTINE AND THE STOMACH WAS VERY PAINFUL, SO THE PATIENT WENT TO THE EMERGENCY ROOM. TREATMENT WAS NOT REPORTED. THE PATIENT WAS HOSPITALIZED FOR 8 DAYS. THE PATIENT DISCONTINUED PD THERAPY AND CHANGED TO HEMODIALYSIS. THE PATIENT RECOVERED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274423 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 DIANEAL 1.5% PD4, EXTRANEAL