BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2223340 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11244
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF ENCAPSULATING PERITONEAL SCLEROSIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 UNKNOWN BAG AND EXTRANEAL VIAFLEX THERAPIES. IN (B)(6) 2007 THE PATIENT STOPPED PD THERAPY AND SWITCHED TO HEMODIALYSIS. IN (B)(6) 2008, THE PATIENT RESUMED PD. IN (B)(6) 2009, THE PATIENT STOPPED PD AND SWITCHED TO HEMODIALYSIS. IN (B)(6) 2009, THE PATIENT RESUMED PD THERAPY. IN (B)(6) 2009, THE PATIENT EXPERIENCED UNDER DIALYSIS WITH CAPD AND "ACOPIA" WITH APD. ON (B)(6) 2010, THE PATIENT WITHDREW FROM PD THERAPY AND SWITCHED TO HEMODIALYSIS. ON (B)(6) 2010, THE PATIENT EXPERIENCED WEIGHT LOSS MARKED BY AN 8KG WEIGHT LOSS IN 4 WEEKS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO WEIGHT LOSS, BILIOUS VOMITING, ABDOMINAL PAIN, CONSTIPATION AND POOR APPETITE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED, HOWEVER IT WAS NOT REPORTED WHETHER THE SYMPTOMS RESOLVED. ON (B)(6) 2010, THE PATIENT RECEIVED REMEDIAL THERAPY WITH CALOGEN (30MLS, FOUR TIMES DAILY, ROUTE NOT REPORTED). ON (B)(6) 2011, THE PATIENT STARTED REMEDIAL THERAPY WITH STRUCTOKABIVEN INTRADIALYTIC PARENTERAL NUTRITION (IDPN) THERAPY (DOSE AND FREQUENCY NOT REPORTED, INTRAVENOUSLY). ON (B)(6) 2011, THE PATIENT WAS READMITTED TO THE HOSPITAL FOR QUESTIONABLE SCLEROSING PERITONITIS. IN (B)(6) 2011, THE PATIENT EXPERIENCED ENCAPSULATING PERITONEAL SCLEROSIS FROM AN UNKNOWN CAUSE MANIFESTED BY WEIGHT LOSS, BILIOUS VOMITING, ABDOMINAL PAIN, CONSTIPATION, POOR APPETITE, ADHESIONS AND AN ABDOMINAL COCOON. IN (B)(6) 2011, THE PATIENT RECEIVED REMEDIAL THERAPY WITH TOTAL PARENTERAL NUTRITION (TPN) (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED). ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. THE EVENT OF ENCAPSULATING PERITONEAL SCLEROSIS WAS ONGOING AND IMPROVED. THE NURSE DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF ENCAPSULATING PERITONEAL SCLEROSIS AND THE RELATIONSHIP TO DIANEAL PD4 UNKNOWN BAG AND EXTRANEAL VIAFLEX THERAPIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R EXTRANEAL VIAFLEX| DIANEAL PD4 UNKNOWN BAG