BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2192418 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10295
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 (B)(4) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF FUNGAL PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). IN 2011, THE PATIENT EXPERIENCED (B)(6) FROM AN UNKNOWN CAUSE. IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED OR WHETHER REMEDIAL THERAPY WAS ADMINISTERED. IT WAS NOT REPORTED WHETHER THE EVENT OF (B)(6) RESOLVED OR WHETHER DIANEAL PD2 ULTRABAG OR EXTRANEAL VIAFLEX THERAPIES WERE ONGOING. THE NURSE STATED THAT THE EVENT OF (B)(6) WAS NOT RELATED TO DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES.

    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 39 YR Other DIANEAL PD2 ULTRABAG| EXTRANEAL VIAFLEX