BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2680992 · Received August 3, 2012

    Report

    Report Number
    1423500-2012-15478
    Event Type
    Injury
    Date Received
    August 3, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 18, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE; HOWEVER, THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED, SINCE WE ARE UNSURE WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. A LABELING REVIEW WAS COMPLETED AND DETERMINED THAT THE INSTRUCTIONS PROVIDE SUFFICIENT LEVEL OF DETAIL ON PREVENTING USE ERROR - BREACH IN ASEPTIC TECHNIQUE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    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 IS NOT AVAILABLE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED HEALTH PROFESSIONAL FROM (B)(6) OF AREA NOT CLEAN BEFORE STARTING PERITONEAL DIALYSIS (PD) AND PERITONITIS IN A (B)(6)MALE PATIENT COINCIDENT WITH DIANEAL ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL ULTRABAG THERAPY, LOT NUMBER 1102021 (DOSE, FREQUENCY AND NOT REPORTED), INTRAPERITONEALLY (IP) FOR PD. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED: ON AN UNREPORTED DATE, THE PATIENT DID NOT CLEAN THE AREA BEFORE STARTING PD, WHICH CAUSED PERITONITIS ON (B)(6) 2012. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENTS. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH REFLIN INJECTION, 1GM, ONCE DAILY, IP AND TOBRAMYCIN INJECTION, 40MG, EVERY 5TH DAY (ROUTE OF ADMINISTRATION NOT REPORTED) FOR PERITONITIS.

    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 52 YR Required Intervention DIANEAL ULTRABAG (B)(6)