BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1954645 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00364
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 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 IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) (LOCAL REFERENCE # (B)(4)) OF DIARRHEA AND PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 ULTRABAG,( LOT NUMBER, DOSE AND FREQUENCY WERE NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE, THE PATIENT DEVELOPED DIARRHEA. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS DIARRHEA. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS AND A PERITONEAL EFFLUENT ANALYSIS AND CULTURE WERE PERFORMED. THE ANALYSIS REVEALED 112 CELLS/MM3 LEUKOCYTES WITH 82% NEUTROPHILS AND 18% LYMPHOCYTES. THE RESULTS OF THE CULTURE WERE UNKNOWN. ON AN UNKNOWN DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFTAZIDIME (LOADING DOSE, IV), SULBACTUM (LOADING DOSE, IV) TINIBA (300MG, BID, PO) AND NORBIT (200MG, BID, PO). DIANEAL THERAPY WAS ONGOING. THE PERITONITIS WAS RESOLVING. THE PATIENT'S MEDICAL HISTORY INCLUDED END STAGE RENAL DISEASE (ESRD)AND HYPERTENSION. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE REPORTER BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO THE DIANEAL THERAPY. NO STATEMENT OF CAUSALITY WAS REPORTED FOR THE DIARRHEA.

    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 57 YR Required Intervention DIANEAL PD2 ULTRABAG