BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2211238 · Received August 15, 2011

    Report

    Report Number
    1423500-2011-10708
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 USE ERROR- POOR ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER-EMPLOYED NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE, CHRONIC CONSTIPATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED CHRONIC CONSTIPATION. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS THE PATIENT MADE A MISTAKE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, WHICH DID NOT REQUIRE HOSPITALIZATION. THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASEPTIC TECHNIQUE, CHRONIC CONSTIPATION AND THE CARE TAKER CHANGED. THE PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED WHETHER THE BREAK IN ASEPTIC TECHNIQUE AND THE CHRONIC CONSTIPATION RESOLVED. IT WAS NOT REPORTED WHETHER REMEDIAL TREATMENT WAS RENDERED. DIANEAL THERAPY WAS ONGOING. THE NURSE STATED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL THERAPY. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE EVENTS BREAK IN ASEPTIC TECHNIQUE AND CHRONIC CONSTIPATION IN RELATION TO DIANEAL.

    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 68 YR Other DIANEAL PD2 ULTRABAG