BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2213812 · Received August 17, 2011

    Report

    Report Number
    1423500-2011-10796
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BAXTER HEALTHCARE
    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 OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF PERITONITIS AND CHRONIC URINARY TRACT INFECTION (UTI) IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS WHICH DID NOT REQUIRE HOSPITALIZATION. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (1 GM, IP, LOADING DOSE) AND GENTAMYCIN (80 MG, IP, ONCE DAILY). AT THE TIME OF THIS REPORT, REMEDIAL THERAPY WITH VANCOMYCIN AND GENTAMYCIN CONTINUED. THE OUTCOME FOR THE EVENTS OF PERITONITIS AND CHRONIC UTI WAS UNKNOWN. DIANEAL THERAPY WAS ONGOING. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. THE NURSE DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF CHRONIC UTI. THE NURSE REPORTED THAT THE CAUSE OF THE PERITONITIS WAS DUE TO CHRONIC URINARY INFECTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention DIANEAL PD2 ULTRABAG