BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1951355 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00190
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 18, 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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR 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) OF PERITONITIS IN A (B)(6) MALE PATIENT SUBSEQUENT TO RECEIVING DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT BEGAN DIANEAL PD2 ULTRABAG THERAPY, MOST RECENT LOT NUMBER 1009081, (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR TREATMENT. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH FORTUM 1 GM DAILY IP AND REFLIN 1 GM DAILY IP (IT WAS NOT REPORTED IF TREATMENT WAS ONGOING). THE ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN. THE OUTCOME OF THE PERITONITIS WAS REPORTED AS UNKNOWN. DIANEAL PD2 ULTRABAG THERAPY WAS REPORTED TO BE ONGOING. THE NURSE CONSIDERED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL PD2 ULTRABAG THERAPY.

    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 64 YR Hospitalization| R DIANEAL PD2 ULTRABAG