BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2191422 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10258
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 16, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    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 SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN FROM THE (B)(6) OF DIARRHEA AND PERITONITIS IN A PATIENT COINCIDENT WITH THE ADMINISTRATION OF DIANEAL PD4 UNKNOWN BAG THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS WITH SYMPTOMS OF CLOUDY DRAIN, ABDOMINAL PAIN, PROLONGED DRAIN, AND DIARRHEA (ONSET DATES OF THE SYMPTOMS WERE NOT REPORTED). WHETHER A PERITONEAL EFFLUENT CULTURE WAS PERFORMED OR WHETHER REMEDIAL TREATMENT WAS RENDERED WAS NOT REPORTED. AT THE TIME OF REPORTING, THE EVENT OF PERITONITIS WAS ONGOING AND UNCHANGED. THE OUTCOME OF THE EVENT OF DIARRHEA WAS NOT REPORTED. DIANEAL THERAPY WAS CONTINUED WITH DOSE UNSPECIFIED. THE EVENT OF PERITONEAL WAS CONSIDERED NOT RELATED TO THE DIANEAL THERAPY. A CAUSALITY ASSESSMENT WAS NOT PROVIDED FOR THE EVENT OF DIARRHEA IN RELATION WITH DIANEAL 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 Other DIANEAL PD4 UNKNOWN BAG