BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1416980-2012-05808

    MDR report key: 2844930 · Received November 26, 2012

    Report

    Report Number
    1416980-2012-05808
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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.

    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. SPECIFICALLY, THE HOME PATIENT DID NOT WEAR A MASK. THE HP WAS HOSPITALIZED FOR THE PERITONITIS FROM (B)(6) 2012 - (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. THE PATIENT IS REPORTEDLY RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization DIANEAL