BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2921071 · Received January 17, 2013

    Report

    Report Number
    1416980-2013-01322
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 IS NOT AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A NURSE IN THE USA OF A BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS COINCIDENT WITH DIANEAL THERAPY. DURING A CALL WITH BAXTER HOME CARE SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH CAUSED PERITONITIS. THE HP WAS HOSPITALIZED FOR THE PERITONITIS FROM (B)(6) 2012. TREATMENT WAS NOT REPORTED. PER THE RN, THE PERITONITIS WAS NOT RELATED TO BAXTER SOLUTIONS, DEVICES OR DISPOSABLE PRODUCTS. SPECIFICALLY, THERE WAS A BREACH IN ASEPTIC TECHNIQUE AND THE HP WAS RETRAINED. THE PATIENT WAS REPORTEDLY RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26187 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization DIANEAL