BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2013394 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02993
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    January 1, 2010
    Report Date
    February 14, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 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 SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF FUNGAL PERITONITIS WITH (B)(6) IN AN APPROXIMATELY (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES. IN (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG (DOSE, FREQUENCY AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). IN 2010, THE PATIENT EXPERIENCED FUNGAL PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT REQUIRED HOSPITALIZATION, OR IF THE PATIENT RECEIVED REMEDIAL THERAPY. THE ROOT CAUSE AND OUTCOME FOR THE EVENT OF FUNGAL PERITONITIS WAS NOT REPORTED. ACTION TAKEN WITH DIANEAL PD4 ULTRABAG, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 UNKNOWN BAG THERAPIES WAS NOT REPORTED. THE NURSE DID NOT PROVIDE A CAUSALITY STATEMENT FOR THE EVENT OF FUNGAL PERITONITIS

    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 46 YR Other DIANEAL PD4 ULTRABAG| NUTRINEAL PD4 UNKNOWN BAG| EXTRANEAL VIAFLEX