BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2873088 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07322
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. 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. 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 IT IS UNCERTAIN 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 CONSUMER IN THE USA OF A BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS COINCIDENT WITH DIANEAL THERAPY. DIANEAL THERAPY WAS ONGOING. 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 PATIENT WAS HOSPITALIZED FOR THE PERITONITIS ON (B)(6) 2012 (DISCHARGE DATE UNKNOWN). TREATMENT WAS NOT REPORTED. PER THE REPORTER, THE PERITONITIS WAS NOT RELATED TO BAXTER SOLUTIONS, DEVICES OR DISPOSABLE PRODUCTS. SPECIFICALLY, THERE WAS A BREACH IN ASEPTIC TECHNIQUE AND THE PATIENT WAS RETRAINED. THE PATIENT WAS RECOVERING FROM THE 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 71 YR Hospitalization DIANEAL