BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2152146 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08739
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG THERAPY (DOSE, FREQUENCY, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. REMEDIAL THERAPY CONSISTED OF VANCOMYCIN (1 GM AT 5 DAYS INTERVAL, IP) AND FORTUM (1 GM, FOR 7 DAYS, FREQUENCY NOT REPORTED, IP). THE PATIENT REMAINED HOSPITALIZED AND REMEDIAL THERAPY WITH VANCOMYCIN AND FORTUM WAS ONGOING. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. THE ACTION TAKEN WITH DIANEAL PD2 ULTRABAG THERAPY WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE BELIEVED THE PERITONITIS WAS UNRELATED TO DIANEAL PD2 ULTRABAG THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R DIANEAL PD2 ULTRABAG