BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1993116 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02038
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 25, 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 GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS WITH CULTURE POSITIVE FOR E COLI IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, FURTHER DESCRIBED AS PATIENT MADE A MISTAKE. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, REQUIRING HOSPITALIZATION. ON (B)(6) 2011, THE PATIENT WAS TREATED WITH MEROPENUM (250MG, ONCE DAILY, IP) AND TOBRAMYCIN (20MG, ONCE DAILY, IP). THE ROOT CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF REPORTING, THE EVENT OF PERITONITIS WAS RESOLVING, THE REMEDIAL THERAPY OF MEROPENUM AND TOBRAMYCIN CONTINUED AND DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING. IT WAS NOT REPORTED IF THE PATIENT RECEIVED RE-TRAINING REGARDING ASEPTIC TECHNIQUE, THEREFORE AN OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL PD2 ULTRABAG THERAPY. THE NURSE DID NOT REPORT ON WHETHER THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS RELATED TO DIANEAL PD2 ULTRABAG THERAPY.

    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 48 YR Hospitalization| R DIANEAL PD2 ULTRABAG