BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1951255 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00191
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 19, 2010
    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER-EMPLOYED NURSE FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE/DID NOT WEAR A MASK/AREA NOT CLEAN BEFORE STARTING PD AND PERITONITIS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (LOT NUMBER 1009010; DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED (DESCRIBED AS PATIENT MADE MISTAKE), THE PATIENT DID NOT WEAR A MASK, AND THE AREA WAS NOT CLEAN BEFORE STARTING PD. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS. A PERITONEAL EFFLUENT CULTURE AND ANALYSIS WERE NOT PERFORMED. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS AND DID NOT RECEIVE ANY REMEDIAL THERAPY. OUTCOME FOR THE EVENT OF PERITONITIS WAS UNKNOWN. OUTCOME FOR THE EVENT BREAK IN ASEPTIC TECHNIQUE/DID NOT WEAR A MASK/AREA NOT CLEAN BEFORE STARTING PD WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE/DID NOT WEAR A MASK/AREA NOT CLEAN BEFORE STARTING PD AND PERITONITIS IN RELATION TO DIANEAL THERAPY. THE REPORTER BELIEVED THE PERITONITIS WAS CAUSED BY THE BREAK IN ASEPTIC TECHNIQUE/DID NOT WEAR A MASK/AREA NOT CLEAN BEFORE STARTING PD.

    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 43 YR Other DIANEAL PD2 ULTRABAG