BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1983333 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01715
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 18, 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 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 GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER-EMPLOYED NURSE FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS WHICH DID NOT REQUIRE HOPSITALIZATION. ON (B)(6) 2011, THE PATIENT RECEIVED REMEDIAL THERAPY WITH LOADING DOSES OF VANCOMYCIN 2GM, IP, AND AMIKACIN 250MG, IP; HEPARIN 2000IU THREE TIMES DAILY, IP; AND REFLIN 1GM, ONCE DAILY, IP. DIANEAL WAS ONGOING. THE EVENT OF PERITONITIS WAS RESOLVED AS OF (B)(6) 2011. THE BAXTER-EMPLOYED NURSE REPORTED THAT THE PERITONITIS WAS UNRELATED TO THE DIANEAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention DIANEAL PD2 ULTRABAG