BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2218167 · Received August 22, 2011

    Report

    Report Number
    1423500-2011-10990
    Event Type
    Injury
    Date Received
    August 22, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 PHYSICIAN IN (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL-N PD-4 1.5 THERAPY FOR CHRONIC RENAL FAILURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DATE. ON AN UNREPORTED DATE, THE PATIENT RECEIVED REMEDIAL TREATMENT WITH UNSPECIFIED ANTIBIOTICS FOR THE EVENT OF PERITONITIS. PER THE PHYSICIAN, THE PATIENT COULD NOT DO ASEPTIC TECHNIQUE WELL, SO THE CAUSE OF THIS EVENT MIGHT BE TOUCH CONTAMINATION. DIANEAL-N PD-4 1.5 THERAPY WAS ONGOING. ON AN UNREPORTED DATE THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PHYSICIAN BELIEVED THE EVENT OF PERITONITIS WAS NOT RELATED TO PD THERAPY.

    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 Hospitalization| R DIANEAL-N PD-4 1.5