BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3112424 · Received May 14, 2013

    Report

    Report Number
    1416980-2013-12317
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED 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 IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT WAS STARTED ON TREATMENT WITH INJECTION (INJ). VANCOTROY (2GM, ONCE DAILY, AND IP) AND GENTAMYCIN (20MG, ONCE DAILY, AND IP) FOR 14 DAYS FOR PERITONITIS. THE OUTCOME OF THIS PERITONITIS EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213314 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention DIANEAL PD2 SINGLE BAG 1.5%