BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2191906 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10273
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 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 REGULATORY REPORT FROM (B)(6) REGULATORY AUTHORITY OF PERITONITIS DUE IN A PATIENT COINCIDENT WITH NUTRINEAL PD4 UNKNOWN BAG THERAPY. IN (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS DUE TO ENTEROBACTER CLOACAE. IT WAS NOT REPORTED IT THE PATIENT WAS HOSPITALIZED FOR THE EVENT OR IF THE PATIENT RECEIVED REMEDIAL TREATMENT. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE OUTCOME FOR THE PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED IF NUTRINEAL THERAPY HAD CONTINUED AT THE TIME OF THE EVENT. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PERITONITIS DUE TO ENTEROBACTER CLOACAE IN RELATION TO NUTRINEAL 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 64 YR Other NUTRINEAL PD4 UNKNOWN BAG