BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2050895 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04373
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 26, 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 GLOBAL PHARMACOVIGILANCE AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON (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, A BREAK IN ASEPTIC TECHNIQUE OCCURRED DESCRIBED AS PATIENT MAKE A MISTAKE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH INJECTION REFLIN (500 MG, THREE TIMES DAILY, IP) AND INJECTION FORTUM (500 MG, THREE TIMES DAILY, IP) WHICH CONTINUED. ON (B)(6) 2011, THE PATIENT ALSO BEGAN REMEDIAL THERAPY WITH INJECTION VANCOMYCIN (1 GM, LOADING DOSE, IP), AND INJECTION AMIKACIN (150 MG, LOADING DOSE, IP). AS OF THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND THE EVENT OF PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING. THE NURSE BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL PD2 ULTRABAG THERAPY AND DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE BREAK IN ASEPTIC TECHNIQUE.

    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 42 YR Hospitalization| R DIANEAL PD2 ULTRABAG