BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2230021 · Received August 31, 2011

    Report

    Report Number
    1423500-2011-11496
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 12, 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 GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF ENTEROGASTRITIS AND STERILE PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON AN UNREPORTED DATE IN 2011, THE PATIENT DEVELOPED ENTEROGASTRITIS. ON AN UNREPORTED DATE IN 2011, THE PATIENT EXPERIENCED STERILE PERITONITIS, WHICH DID NOT REQUIRE HOSPITALIZATION. THE CAUSE OF THE PERITONITIS WAS THE ENTEROGASTRITIS. ON AN UNREPORTED DATE IN 2011, THE PERITONITIS RESOLVED. THE OUTCOME FOR ENTEROGASTRITIS WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER THE PATIENT WAS TREATED FOR THE EVENTS OR WHETHER DIANEAL THERAPY CONTINUED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE REPORTED THAT THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. AN ASSESSMENT OF CAUSALITY WAS NOT PROVIDED FOR THE ENTEROGASTRITIS.

    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 62 YR Other DIANEAL PD2 AMBUFLEX