BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961404 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00613
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL 35 UNKNOWN BAG THERAPY. IN (B)(6) 2010 , THE PATIENT STARTED TREATMENT WITH EXTRANEAL VIAFLEX, LOT NUMBER 10D12G42, AND PHYSIONEAL 35 (DOSE AND FREQUENCY WERE NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE THE PATIENT'S PERITONEAL DIALYSIS CATHETER WAS REMOVED DUE TO BACTERIAL PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT WAS TEMPORARILY TRANSFERRED TO HEMODIALYSIS. ACTION TAKEN WITH EXTRANEAL VIAFLEX AND PHYSIONEAL IS WITHDRAWN. IT WAS NOT REPORTED IF THE PERITONITIS RESOLVED. NO CAUSALITY STATEMENT WAS REPORTED FOR THE PERITONITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention PARAPRES (CANDESARTAN CILEXETIL),| EXTRANEAL VIAFLEX AND PHYSIONEAL 35, FUROSEMIDE,| ARTEDIL (MANDIPINE), DOXAZOSIN, ROCALTORL