BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2040258 · Received April 5, 2011

    Report

    Report Number
    1423500-2011-04128
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 14, 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 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.

    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 COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. IN (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED DIARRHEA. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR DIARRHEA. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH TAZIN (2.25GM, THREE TIMES DAILY, IP), TRAXTON Z (1.25GM, TWICE DAILY, IP), RAZO (20MG, TWICE DAILY, IP), PERINORM (1AMP, THREE TIMES DAILY, IP), DROTIN (1AMP, THREE TIMES DAILY, IP) AND NITAZOX (500MG, THREE TIMES DAILY, IP). ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH UNIZOX (1GM, DAILY, IP). AT THE TIME OF REPORTING, THE PATIENT REMAINED HOSPITALIZED DUE TO THE DIARRHEA, THE EVENTS OF PERITONITIS AND DIARRHEA WERE RESOLVING/RECOVERING AND THE PATIENT CONTINUED REMEDIAL THERAPY WITH TAZIN, TRAXTON Z, RAZO, PERINORM, DROTIN, NITAZOX AND UNIZOX. DIANEAL PD2 ULTRABAG THERAPY CONTINUED.

    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 50 YR Required Intervention DIANEAL PD2 ULTRABAG