BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2192651 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10314
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 23, 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 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. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR- POOR ASEPTIC TECHNIQUE.

    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. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS THE PATIENT MADE A MISTAKE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, WHICH DID NOT REQUIRE HOSPITALIZATION. THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH FORTUM (1GM, ONCE DAILY, INTRAVENOUSLY) AND VANCOMYCIN (1GM, LOADING DOSE, INTRAVENOUSLY). CONCOMITANT MEDICATIONS WERE NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE, THEREFORE, THE OUTCOME IS UNKNOWN. THE PERITONITIS WAS RESOLVING. DIANEAL THERAPY WAS ONGOING AS WAS REMEDIAL THERAPY WITH FORTUM. THE NURSE BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY AND DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR 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 62 YR Required Intervention DIANEAL PD2 ULTRABAG