BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2040259 · Received April 5, 2011

    Report

    Report Number
    1423500-2011-04129
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 14, 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 DEVICE INVOLVED IN THE INCIDENT WAS 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY. ON (B)(6) 2010, THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 UNKNOWN BAG, (FREQUENCY NOT REPORTED), INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS WHICH WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH A GENTAMYCIN. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE PERITONITIS WAS RESOLVED. IT WAS UNKNOWN IF THE DIANEAL THERAPY WAS ONGOING. THE REPORTER BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE 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 82 YR Hospitalization| R DIANEAL PD2 UNKNOWN BAG