BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2103292 · Received May 26, 2011

    Report

    Report Number
    1423500-2011-06520
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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 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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A (B)(6) MALE COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS ATTENDANT DOING CAPD WITHOUT PROPER TRAINING FROM BAXTER CLINICAL COORDINATOR. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS DUE TO THE BREAK IN ASEPTIC TECHNIQUE AND WAS NOT HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH REFLIN (1G, ONCE DAILY, ROUTE NOT REPORTED). ON AN UNREPORTED DATE, THE EVENT OF PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED IF THE PATIENT OR THEIR ATTENDANT WERE RETRAINED IN PROPER ASEPTIC TECHNIQUE. IT WAS NOT REPORTED WHETHER DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING. THE NURSE DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE OR PERITONITIS. FOLLOW UP INFORMATION (18MAY2011): FOLLOW UP INFORMATION WAS PROVIDED BY A NURSE. ON AN UNREPORTED DATE, THE PATIENT ENDED REMEDIAL THERAPY WITH REFLIN AND THE EVENT OF PERITONITIS RESOLVED.

    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 49 YR Required Intervention DIANEAL PD2 ULTRABAG