BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961631 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00637
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 20, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 SOLICITED REPORT BY A NURSE FROM (B)(6) OF PERITONITIS OF MODERATE SEVERITY IN A (B)(6) MALE PATIENT SUBSEQUENT TO RECEIVING EXTRANEAL VIAFLEX AND PHYSIONEAL UNSPECIFIED THERAPIES (LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) DURING PERITONEAL DIALYSIS (PD) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT AND WAS HOSPITALIZED. ON THAT SAME DATE, A PERITONEAL EFFLUENT ANALYSIS REVEALED A LEUCOCYTE COUNT OF 18400 CELLS/MM*3, NEUTROPHILS 95%, AND MONOCYTES 5%. THE PATIENT BEGAN VANCOMYCIN 100 MG IP QDS, AND CEFTAZIDIME 250 MG IP QDS. ON (B)(6) 2010, THE PATIENT HAD A PERITONEAL EFFLUENT CULTURE PERFORMED THAT REVEALED NO GROWTH. ON (B)(6) 2010, THE PATIENT WAS SWITCHED TO VANCOMYCIN 50 MG BD, THEN 2 GMS VANCOMYCIN, THEN 1 GRAM VANCOMYCIN. EXTRANEAL VIAFLEX AND PHYSIONEAL UNSPECIFIED THERAPIES WERE ONGOING . ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED, HOWEVER, TREATMENT WAS COMPLETED ON (B)(6) 2010. THE REPORTER WAS UNABLE TO ASSESS WHETHER THE PERITONITIS WAS RELATED TO EXTRANEAL VIAFLEX AND PHYSIONEAL UNSPECIFIED THERAPIES.

    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 32 YR Hospitalization| R VIAFLEX| EXTRANEAL| PHYSIONEAL