BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1933041 · Received December 20, 2010

    Report

    Report Number
    1423500-2010-07065
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 4, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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 AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT BEGAN AUTOMATIC PERITONEAL DIALYSIS (APD). ON UNKNOWN DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (2L DAILY, LOT NUMBERS NOT REPORTED), PHYSIONEAL 35 1.36% (10L DAILY, LOT NUMBERS NOT REPORTED), AND PHYSIONEAL 35 2.27% (2.5L DAILY, LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR APD. ON (B)(6) 2010, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND CLOUDY EFFLUENT AND WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH REVEALED (B)(6). ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL TREATMENT WITH VANCOMYCIN 2G (ACCORDINGLY TO VANCOMYCIN SERUM LEVELS, IP). ON AN UNKNOWN DATE IN (B)(6) 2010, REMEDIAL TREATMENT WAS SWITCHED TO VANCOMYCIN 500MG (ACCORDINGLY TO VANCOMYCIN SERUM LEVELS, IP). THE PATIENT WAS RECOVERING FROM THE PERITONITIS, WITH NO SYMPTOMS. THE PATIENT HAD NO ABDOMINAL PAIN AND PERITONEAL EFFLUENT WAS CLEAR. REMEDIAL TREATMENT WITH VANCOMYCIN WAS ONGOING. EXTRANEAL VIAFLEX AND PHYSIONEAL 35 WERE ONGOING, DOSE UNCHANGED. THE NURSE BELIEVED THE PERITONITIS WAS NOT RELATED TO EXTRANEAL VIAFLEX AND PHYSIONEAL 35 THERAPIES AND BELIEVED IT WAS A RECURRENCE OF THE PERITONITIS ON (B)(6) 2010. NO FURTHER INFORMATION IS AVAILABLE.

    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 67 YR Required Intervention PHYSIONEAL 35 1.36% (10L DAILY)| PHYSIONEAL 35 2.27% (2.5L DAILY)| EXTRANEAL VIAFLEX (2L DAILY)