BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1992291 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-02017
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 24, 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 A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS THE PATIENT MADE A MISTAKE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. THE CAUSE OF THE PERITONITIS WAS DUE TO THE BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH FORTUM (1GM, DAILY, IP) AND AMIKACIN (125MG, DAILY, IP). AT THE TIME OF THIS REPORT THE PATIENT WAS STILL HOSPITALIZED. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN PROPER ASEPTIC PROCEDURE. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING. THE NURSE DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE AND STATED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL PD2 ULTRABAG THERAPY.

    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 57 YR Hospitalization| R DIANEAL PD2 ULTRABAG