BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 1998120 · Received February 22, 2011

    Report

    Report Number
    1423500-2011-02310
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 29, 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS A SPONTANEOUS REPORT BY A HEALTHCARE PROFESSIONAL FROM (B)(6) OF PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) (LOT NUMBER 1010030) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. ON (B)(6) 2011, THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION 1 GRAM IP ONCE DAILY (CONTINUING) AND AMIKACIN INJECTION 250 MG IP ONCE DAILY (CONTINUING). ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2011, THE EVENT OF PERITONITIS RESOLVED AND REMEDIAL TREATMENT WITH VANCOMYCIN AND AMIKACIN WERE DISCONTINUED. DIANEAL THERAPY WAS ONGOING. THE REPORTER STATED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL. THE ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R DIANEAL PD2 ULTRABAG