BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1980212 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01565
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 15, 2011
    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 CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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 COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. IN (B)(6) 2010, THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 ULTRABAG, (DOSE AND FREQUENCY WERE NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (1GM, LOADING DOSE, IP) AND AMIKACIN (250MG, DAILY, IP). ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. IT WAS UNKNOWN IF THE DIANEAL THERAPY WAS ONGOING OR IF THE PERITONITIS WAS RESOLVING. THE REPORTER BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL 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 56 YR Hospitalization| R