BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2231887 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11599
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    March 1, 2009
    Report Date
    August 15, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT UNDERWENT AN UNSPECIFIED MINOR SURGERY FOR AN UNREPORTED INDICATION. WHILE IN THE HOSPITAL FOR THIS MINOR SURGERY, THE PATIENT PERFORMED AN EXCHANGE AND WAS NOT SUPPOSED TO, WHICH RESULTED IN PERITONITIS. ON AN UNREPORTED DATE IN (B)(6) 2009, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2009, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT HAD RECOVERED FROM THE EVENT OF PERITONITIS. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN AND THE PATIENT WAS STARTED ON HEMODIALYSIS. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY. THE NURSE DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    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 57 YR Hospitalization DIANEAL PD4 ULTRABAG