BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2072232 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05158
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 7, 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 PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG, (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE (DESCRIBED AS PATIENT MADE A MISTAKE). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, REQUIRING HOSPITALIZATION THAT DAY. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL TREATMENT WITH IP INJECTIONS OF FORTUM SINGLE BAG 1000MG, AND AMIKACIN 125 MG ONE BAG ALTERNATIVE DAYS. AT THE TIME OF THIS REPORT THE PATIENT REMAINED HOSPITALIZED AND THE OUTCOME FOR THE EVENT OF PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RE-TRAINED IN ASEPTIC TECHNIQUE; THEREFORE THE OUTCOME OF BREAK IN ASEPTIC TECHNIQUE IS UNKNOWN. TREATMENT WITH DIANEAL PD2 THERAPY WAS ONGOING. ACCORDING TO THE NURSE, IT WAS UNKNOWN WHETHER THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS WAS RELATED TO DIANEAL PD2 ULTRABAG.

    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 74 YR Hospitalization| R DIANEAL PD2 ULTRABAG