BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2897130 · Received January 4, 2013

    Report

    Report Number
    1416980-2013-00281
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 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 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 IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED HEALTH PROFESSIONAL FROM (B)(6) OF A HOME PATIENT (HP) THAT MADE A MISTAKE/BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS COINCIDENT WITH DIANEAL THERAPIES. DURING A CALL WITH BAXTER INDIA TECHNICAL SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE MISTAKE AND A BREAK IN ASEPTIC TECHNIQUE OCCURRED WHICH CAUSED PERITONITIS. ON (B)(6) 2012, THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION FORTUM (250GM EVERY 3 BAGS), INJECTION REFLIN (250GM) AND INJECTION HEPARIN (1000IU), (ROUTES AND FREQUENCIES, NOT REPORTED) FOR PERITONITIS. THE HP IS REPORTEDLY RECOVERING FROM THE PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5300 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R DIANEAL THERAPY