BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2132844 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07785
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 CONSUMER FROM (B)(6) OF CONSTIPATION AND PERITONITIS WITH CULTURE POSITIVE FOR A GRAM NEGATIVE ORGANISM IN PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSAGE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, NOT REQUIRING HOSPITALIZATION. TREATMENT INCLUDED IP CEFAZOLIN, 500 MG IN EACH BAG, AND IP AMIKACIN, 100 MG IN EACH BAG. THE OUTCOME OF THE PERITONITIS AND CONSTIPATION WAS REPORTED AS UNKNOWN. ACTION TAKEN WITH DIANEAL WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTER CONSIDERED THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE ORGANISM TO BE UNRELATED TO DIANEAL AND CONSIDERED THE CAUSE TO BE CONSTIPATION.

    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 73 YR Required Intervention DIANEAL PD2 ULTRABAG