BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2132091 · Received June 16, 2011

    Report

    Report Number
    1423500-2011-07734
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 26, 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 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 THIS INCIDENT WAS DETERMINED TO BE USE ERROR-BREAK IN ASEPTIC TECHNIQUE.

    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 PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNSPECIFIED DATE IN (B)(6) 2011, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS "PATIENT MADE MISTAKE." ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT OF PERITONITIS. REMEDIAL TREATMENT INCLUDED INJECTION OF VANCOMYCIN, 1 GM IP "STAT" DAILY FOR 5 DAYS AND FORTUM 1 GM IP INITIATED ON (B)(6) 2011. THE OUTCOME OF THE EVENT OF PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED FOR ASEPTIC TECHNIQUE; THEREFORE, THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. DIANEAL PD4 ULTRABAG WAS CONTINUED WITH DOSE UNSPECIFIED. CONCOMITANT MEDICATION WAS NOT REPORTED. THE EVENT OF PERITONITIS WAS ASSESSED AS UNRELATED TO DIANEAL PD4 ULTRABAG THERAPY. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE IN RELATION TO DIANEAL PD4 ULTRABAG THERAPY.

    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 52 YR Required Intervention DIANEAL PD4 ULTRABAG