BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2103002 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06491
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 6, 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, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED AND THE RESULTS REVEALED NO GROWTH. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2011, REMEDIAL THERAPY WITH CEFAZOLINE, TAZOBACTAM, AMIKACIN AND HEPARIN WAS DISCONTINUED AND THE EVENT OF PERITONITIS HAD RESOLVED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS A SPONTANEOUS REPORT BY A BAXTER-EMPLOYED NURSE FROM (B)(6) OF PERITONITIS PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG THERAPY (DOSE AND FREQUENCY NOT REPORTED, LOT NUMBER 1101073) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFAZOLINE (500 MG, DAILY, IP), TAZOBACTAM (500 MG, DAILY, IP), AMIKACIN (125 MG, DAILY, IP) AND HEPARIN (1000 IU, THRICE DAILY, IP). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. AT THE TIME OF THIS REPORT, DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING AND THE OUTCOME FOR THE EVENT OF PERITONITIS WAS UNKNOWN. THE NURSE CONSIDERED THE EVENT OF PERITONITIS TO BE UNRELATED TO DIANEAL PD2 ULTRABAG THERAPY.

    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 47 YR Hospitalization DIANEAL PD2 ULTRABAG