BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2153073 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08774
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A LITERATURE REPORT FROM (B)(6) OF ENCAPSULATING PERITONEAL SCLEROSIS (EPS) IN A PATIENT (AGE AND GENDER NOT REPORTED) SUBSEQUENT TO THERAPY WITH EXTRANEAL. THIS RETROSPECTIVE STUDY REVIEWED A TOTAL OF 1966 RECORDS OF PATIENTS TREATED WITH CHRONIC PERITONEAL DIALYSIS (PD) BETWEEN 1974 AND 2008. THE AUTHORS "TWO-HIT" HYPOTHESIS PRESUPPOSED THAT, IN ADDITION TO LONG-TERM CHANGES IN PERITONEAL MEMBRANE DUE TO EXPOSURE TO BIOINCOMPATIBLE SOLUTIONS, (FIRST HIT), ONE OR MORE OTHER FACTORS (SECOND HIT) ARE NECESSARY FOR THE DEVELOPMENT OF EPS. SUCH OTHER FACTORS INCLUDED RECURRENT OR SEVERE PERITONITIS, DISCONTINUATION OF PD, EXPOSURE TO PRO-FIBROTIC IMMUNOSUPPRESSIVE DRUGS AFTER TRANSPLANTATION AND POSSIBLY A GENETIC PREDISPOSITION. THE DIAGNOSIS OF EPS WAS MADE IF THERE WAS EITHER SURGICAL OR RADIOLOGICAL EVIDENCE OF ENCAPSULATING PERITONEAL SCLEROSIS (EPS), WITH SIGNS OF SMALL BOWEL OBSTRUCTION, ALONG WITH SEVERE MALNUTRITION. THE MEAN DURATION OF PERITONEAL DIALYSIS WHEN EPS WAS DIAGNOSED WAS 6.5 YEARS WITH A MEDIAN OF 7 AND RANGE OF 1-14 YEARS. ALL PATIENTS HAD A SERUM ALBUMIN <32 G/L. THERE WERE MULTIPLE REPORTS FROM THIS ARTICLE. THIS IS REPORT 20 OF 21 FOR THIS LITERATURE REPORT. 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

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A LITERATURE CITATION FROM: TRIGKA K, DOUSDAMPANIS P, CHU M, KHAN S, AHMAD M, BARGMAN JM ET AL. ENCAPSULATING PERITONEAL SCLEROSIS: A SINGLE CENTER EXPERIENCE AND REVIEW OF THE LITERATURE. INT UROL NEPHROL. 2011; 43: 519.526. THIS IS A LITERATURE REPORT FROM (B)(6) OF ENCAPSULATING PERITONEAL SCLEROSIS (EPS) IN A PATIENT (AGE AND GENDER NOT REPORTED) SUBSEQUENT TO THERAPY WITH EXTRANEAL. ON AN UNREPORTED DATE THE PATIENT EXPERIENCED ENCAPSULATING PERITONEAL SCLEROSIS SUBSEQUENT TO PD THERAPY WITH ICODEXTRIN (BRAND/MANUFACTURER, FREQUENCY, AND DOSE NOT REPORTED). NO OTHER INFORMATION WAS REPORTED AS TO THE OUTCOME OR TREATMENT OF THE EVENT, OR ACTION TAKEN WITH THE STUDY MEDICATION. ACCORDING TO THE AUTHORS, "THE APPEARANCE OF EPS HAS ALSO BEEN LINKED WITH THE CHARACTERISTICS OF THE DIALYSIS SOLUTION USED. STANDARD SOLUTIONS ARE BIOINCOMPATIBLE WITH A LOW PH AND HIGH GLUCOSE CONCENTRATION AND OSMOLALITY ALONG WITH THE HIGH CONCENTRATION OF GLUCOSE DEGRADATION PRODUCTS. IN OUR STUDY, 11 PATIENTS WERE TREATED WITH HYPERTONIC DEXTROSE SOLUTIONS (4.25%) WITHIN THE LAST YEAR BEFORE EPS WAS DIAGNOSED, INDIRECT EVIDENCE OF UF FAILURE. IT IS DIFFICULT TO DETERMINE WHETHER THE USE OF 4.25% DEXTROSE REFLECTS UF FAILURE IN THE EARLY STAGES OF EPS, OR WHETHER THESE SOLUTIONS PROMOTED EPS. SEVEN OF OUR PATIENTS HAD BEEN USING ICODEXTRIN SOLUTIONS. THREE OF THESE 7 USED ICODEXTRIN SOLUTIONS WITHIN THE YEAR BEFORE EPS WAS DIAGNOSED. TWO OF THEM HAVE BEEN USING 4.25% DEXTROSE SOLUTIONS SIMULTANEOUSLY WITHIN THE LAST YEAR BEFORE EPS WAS DIAGNOSED."

    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 Other