BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1998456 · Received February 23, 2011

    Report

    Report Number
    1423500-2011-02327
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 3, 2011
    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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A BAXTER-EMPLOYED NURSE FROM (B)(6) OF A PATIENT WHO MADE A MISTAKE/BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, FURTHER DESCRIBED AS THE PATIENT MADE A MISTAKE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR PERITONITIS AND DID NOT RECEIVE ANY REMEDIAL THERAPY. OUTCOME FOR THE PERITONITIS WAS UNKNOWN. OUTCOME FOR THE EVENT OF PATIENT MADE MISTAKE/BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. THE REPORTER BELIEVED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PATIENT MADE MISTAKE/BREAK IN ASEPTIC TECHNIQUE IN RELATION TO DIANEAL THERAPY. FOLLOW UP INFORMATION ((B)(6) 2011): THE BATCH RECORD AND ANALYTICAL RESULTS FOR DIANEAL PD2 ULTRABAG LOT NUMBER 1010019 HAVE BEEN REVIEWED AND FOUND TO BE COMPLIANT WITH THE STANDARD SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other DIANEAL PD2 ULTRABAG