BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2011121 · Received March 8, 2011

    Report

    Report Number
    1423500-2011-02873
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BAXTER HEALTHCARE
    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 EMPLOYEE NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, NOT REQUIRING HOSPITALIZATION. ON (B)(6) 2011, THE PATIENT WAS TREATED WITH REFLIN INJECTION 1GM ONCE DAILY, IP AND VANCOMYCIN INJECTION 1GM ONCE DAILY, IP. THE ROOT CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS THE PATIENT MADE A MISTAKE. ON AN UNREPORTED DATE, THE PERITONITIS WAS RESOLVING. REFLIN AND VANCOMYCIN TREATMENT WERE ONGOING. DIANEAL PD2 ULTRABAG THERAPY WAS CONTINUED. THE REPORTER BELIEVED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL PD2 ULTRABAG THERAPY. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention DIANEAL PD2 ULTRABAG