BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1963006 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00721
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 28, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 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 REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF STERILE PERITONITIS AND C-REACTIVE PROTEIN ELEVATION IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX (LOT NUMBER 10H23G41) AND PHYSIONEAL 35 2.27% UNKNOWN BAG (LOT NUMBER 10H18G10 AND 10I10G12) THERAPIES, INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, THE PATIENT HAD C-REACTIVE PROTEIN ELEVATION. ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY ABDOMINAL DISCOMFORT "AFTER EXTRANEAL VIAFLEX FILLS" AND "DRAINS OF" CLOUDY EFFLUENT. ON THAT SAME DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFAZOLINE (DOSE AND FREQUENCY NOT REPORTED, IP) AND CEFTAZIDIME (DOSE AND FREQUENCY NOT REPORTED, IP) "PER PERITONITIS PROTOCOL". THE PATIENT DID NOT REQUIRE HOSPITALIZATION. ON AN UNREPORTED DATE, THE EXTRANEAL VIAFLEX THERAPY WAS WITHDRAWN. IT WAS UNKNOWN WHETHER THE PATIENT IMPROVED SPECIFICALLY WITH THE DISCONTINUATION OF THE EXTRANEAL VIAFLEX THERAPY. IT WAS NOT REPORTED WHETHER EXTRANEAL VIAFLEX WAS REINTRODUCED. IT WAS NOT REPORTED WHETHER PHYSIONEAL 35 2.27% WAS ONGOING. IT WAS UNKNOWN WHETHER THE EVENTS OF STERILE PERITONITIS AND C-REACTIVE PROTEIN ELEVATION HAD RESOLVED. THE PHYSICIAN CONSIDERED THE EVENT OF STERILE PERITONITIS TO BE RELATED TO EXTRANEAL VIAFLEX BUT NOT RELATED TO PHYSIONEAL 35 2.27% UNKNOWN BAG THERAPIES. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY STATEMENT FOR THE EVENT OF C-REACTIVE PROTEIN ELEVATION.

    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 82 YR Required Intervention HEPARIN (IP)