BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1970722 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01038
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 6, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    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 MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT 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 (GPV) AND IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF STERILE PERITONITIS IN A PATIENT, COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT, AND WAS HOSPITALIZED (DATE NOT REPORTED). THE SEVERITY OF THE PERITONITIS WAS MODERATE. ON AN UNREPORTED DATE, THE PATIENT RECEIVED REMEDIAL THERAPY WITH CEPHRADINE 1GM, IP FOR A 6 HOUR DWELL, ONCE DAILY; AND GENTAMYCIN 0.6MG/KG, IP FOR A 6 HOUR DWELL, "AS PER LEVEL." ON AN UNREPORTED DATE, EXTRANEAL VIAFLEX WAS DISCONTINUED AND WAS NOT REINTRODUCED. ALTHOUGH IT WAS REPORTED THE PATIENT "IMPROVED SPECIFICALLY" ONCE THE EXTRANEAL WAS DISCONTINUED, ALONG WITH THE INITIATION OF THE ANTIBIOTIC THERAPY, THE OUTCOME FOR THE EVENT OF STERILE PERITONITIS WAS NOT REPORTED. THE NURSE REPORTED THE EVENT OF STERILE PERITONITIS WAS RELATED TO THE EXTRANEAL.

    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 23 YR Hospitalization| R EXTRANEAL VIAFLEX