BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961582 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00632
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 27, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A REGULATORY REPORT BY A PHYSICIAN WITH SUPPLEMENTAL INFORMATION BY THE (B)(4) HEALTH AUTHORITIES FROM (B)(4) OF APYRETIC, ASEPTIC PERITONITIS IN A PATIENT SUBSEQUENT TO RECEIVING EXTRANEAL VIAFLEX THERAPY, LOT NUMBER 10I26G37, 1.5 L DAILY, INTRAPERITONEALLY (IP) DURING PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT DEVELOPED APYRETIC, ASEPTIC PERITONITIS MANIFESTED BY ABDOMINAL PAIN. ON (B)(6) 2010, 72 HOURS AFTER THE CULTURE RESULTS, EXTRANEAL VIAFLEX THERAPY WAS WITHDRAWN. THE PATIENT RECEIVED TREATMENT WITH TAZOCILLINE 4 G THREE TIMES DAILY FOR 5 TO 7 DAYS, AMIKLIN 750 MG DAILY FOR THREE DAYS, AND FLAGYL 500 MG THREE TIMES DAILY. THE APYRETIC, ASEPTIC PERITONITIS HAD NOT RESOLVED. THE REPORTER BELIEVED THE APYRETIC, ASEPTIC PERITONITIS WAS POSSIBLY RELATED TO EXTRANEAL VIAFLEX THERAPY. THE (B)(4) HEALTH AUTHORITIES CONSIDERED EXTRANEAL AS A SUSPECT MEDICATION, AND THE CAUSAL RELATIONSHIP WAS RATED, ACCORDING TO THE (B)(4) METHODOLOGY OF CAUSALITY ASSESSMENT, AS DOUBTFUL (PREVIOUSLY REPORTED AS POSSIBLY RELATED).

    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 72 YR Required Intervention EXTRANEAL VIAFLEX THERAPY, LOT NUMBER 10I26G37