BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2113085 · Received June 3, 2011

    Report

    Report Number
    1423500-2011-07038
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 12, 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 IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX AND DIANEAL PD2 ULTRABAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT STARTED TREATMENT WITH DIANEAL AMBUFLEX AND DIANEAL PD2 ULTRABAG (DOSES AND FREQUENCIES WERE 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. ON AN UNKNOWN DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (1GM, LOADING DOSE FOR THE FIRST TWO DAYS, IP) AND FORTUM (1GM, IP). THE PATIENT THEN BEGAN THERAPY WITH VANCOMYCIN (500MG, 250MG, 250MG, IN EACH OF THREE BAGS FOR THE DAY, IP). THE VANCOMYCIN WAS ONGOING. IT WAS UNKNOWN IF THE DIANEAL THERAPY WAS ONGOING OR IF THE PERITONITIS WAS RESOLVING. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE NURSE BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL 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 50 YR Hospitalization| R DIANEAL PD2 AMBUFLEX| DIANEAL PD2 ULTRABAG