BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2093783 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06162
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 24, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT BY A PHYSICIAN FROM (B)(6) OF CHOLECYSTITIS AND PERITONITIS IN A FEMALE PATIENT (B)(6) COINCIDENT WITH DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 THERAPIES. ON (B)(6) 2007, THE PATIENT BEGAN TREATMENT WITH DIANEAL-N PD4 1.5 (1500ML, ONCE A DAY, LOT NUMBER NOT REPORTED) AND DIANEAL-N PD4 2.5 (2500ML, 3 TIMES DAILY, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CHRONIC RENAL FAILURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED CHOLECYSTITIS AND PERITONITIS AND WAS HOSPITALIZED. THE PHYSICIAN STATED THAT THE PERITONITIS WAS DUE TO THE CHOLECYSTITIS AND THE CHOLECYSTITIS WAS RELATED TO THE PATIENT'S MEDICAL HISTORY OF GASTROINTESTINAL INFLAMMATION. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH UNSPECIFIED MEDICATIONS INDICATED FOR THE CHOLECYSTITIS AND PERITONITIS. ON (B)(6) 2011, THE EVENT OF CHOLECYSTITIS RESOLVED. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED WHETHER THE PATIENT WAS STILL HOSPITALIZED. DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 THERAPIES WERE ONGOING. THE PHYSICIAN STATED THAT THE EVENTS OF CHOLECYSTITIS AND PERITONITIS WERE NOT RELATED TO DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 THERAPIES.

    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 Hospitalization| R DIANEAL-N PD4 2.5| DIANEAL-N PD4 1.5