BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2094319 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06177
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 25, 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 ROOT CAUSE IS UNDETERMINED. THE DEVICE INVOLVED IN THE INCIDENT WAS 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2011, THE PATIENT'S CATHETER WAS REMOVED. ON THE SAME DAY, REMEDIAL TREATMENT WITH REFLIN AND TOBRAMYCIN WAS DISCONTINUED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED WITH SEQUELAE (DATE NOT PROVIDED).

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED HEALTHCARE PROFESSIONAL FROM (B)(6) OF PERITONITIS WITH (B)(6) COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSE, FREQUENCY NOT REPORTED) (LOT NUMBER 1010029) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT DEVELOPED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND BEGAN TREATMENT WITH REFLIN (1 GRAM, IP, ONCE DAILY, CONTINUING) AND TOBRAMYCIN (1 GRAM, IP, LOADING DOSE, CONTINUING). THE OUTCOME FOR THE EVENT OF PERITONITIS WAS NOT REPORTED. 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 BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R DIANEAL PD2 ULTRABAG