BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961405 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00619
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 28, 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 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 IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX, NUTRINEAL PD4 UNKNOWN BAG (LOT NUMBER 10J13G37) AND PHYSIONEAL 40 UNKNOWN BAG THERAPIES, INTRAPERITONEALLY (IP) FOR APD (AUTOMATED PERITONEAL DIALYSIS). ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. BEGINNING (B)(6) 2010, THE PATIENT RECEIVED REMEDIAL TREATMENT WITH GENTAMYCIN 40MG DAILY IP WHICH CONTINUED UNTIL (B)(6) 2010 AND VANCOMYCIN 1 GM "4 DAYS" IP WHICH CONTINUED UNTIL (B)(6) 2010. ON (B)(6) 2010, THE PATIENT RECOVERED. PD THERAPY CONTINUED. THE PHYSICIAN CLASSIFIED THE EVENT AS MILD. THE PHYSICIAN BELIEVED THE EVENT WAS RELATED TO NUTRINEAL AND UNRELATED TO EXTRANEAL AND PHYSIONEAL.

    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 34 YR Required Intervention EXTRANEAL VIAFLEX, NUTRINEAL PD4, PHYSIONEAL 40