BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2012553 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02973
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF BACTERIAL PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX, PHYSIONEAL, UNSPECIFIED PRODUCT AND NUTRINEAL PD4 UNKNOWN BAG THERAPY (LOT NUMBERS NOT REPORTED). ON AN UNREPORTED DATE, APPROXIMATELY 2 YEARS PRIOR TO THIS REPORT, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX, PHYSIONEAL, UNSPECIFIED PRODUCT AND NUTRINEAL PD4 UNKNOWN BAG (DOSE, FREQUENCY AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) PERITONEAL DIALYSIS (PD). IN (B)(6) 2011, THE PATIENT EXPERIENCED CLOUDY EFFLUENT WITHOUT PAIN OR OTHER CLINICAL SIGNS, AND WAS HOSPITALIZED. IN (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT BEGAN REMEDIAL TREATMENT WITH UNSPECIFIED ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED). ON (B)(6) 2011, THE PATIENT'S REMEDIAL TREATMENT WITH UNSPECIFIED ANTIBIOTICS ENDED. THE OUTCOME FOR BACTERIAL PERITONITIS WAS NOT REPORTED. EXTRANEAL, PHYSIONEAL AND NUTRINEAL THERAPIES CONTINUED. THE PHYSICIAN BELIEVED THE EVENT OF BACTERIAL PERITONITIS WAS UNRELATED TO EXTRANEAL, PHYSIONEAL AND NUTRINEAL THERAPIES.

    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 79 YR Hospitalization| R NUTRINEAL PD4 UNKNOWN BAG