BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2152223 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08748
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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 IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT FROM THE (B)(6) OF BLOODY VOMITUS AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2, UNKNOWN BAG THERAPY. IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2, UNKNOWN BAG THERAPY (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN FOR 3 DAYS, CLOUDY EFFLUENT, AND ONE EPISODE OF BLOODY VOMITUS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. IT WAS NOT REPORTED IF REMEDIAL TREATMENT WAS RECEIVED, IF THE EVENT OF PERITONITIS OR BLOODY VOMITUS RESOLVED, OR IF DIANEAL PD2 THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE CONSUMER DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENTS OF PERITONITIS OR BLOODY VOMITUS.

    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 19 YR Hospitalization DIANEAL PD2