BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2023749 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03375
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THE INCIDENT WAS 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE AND IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF STERILE PERITONITIS COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX IP FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY ABDOMINAL PAIN. ON THE SAME DAY, THE PATIENT BEGAN REMEDIAL THERAPY WITH KEFZOL (250MG, FREQUENCY NOT REPORTED, IP). ON AN UNREPORTED DATE, EXTRANEAL VIAFLEX WAS WITHDRAWN AND THE PATIENT SPECIFICALLY IMPROVED WITH THE DISCONTINUATION OF THE PRODUCT. ON (B)(6) 2011, REMEDIAL THERAPY WITH KEFZOL ENDED. ON (B)(6) 2011, THE PATIENT RECOVERED FROM THE STERILE PERITONITIS. ON AN UNREPORTED DATE, EXTRANEAL VIAFLEX WAS REINTRODUCED. THE PHYSICIAN STATED THAT THE EVENT OF STERILE PERITONITIS WAS RELATED TO THE EXTRANEAL VIAFLEX THERAPY.

    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 35 YR Required Intervention EXTRANEAL VIAFLEX