BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KDJ - SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2743067 · Received September 13, 2012

    Report

    Report Number
    1423500-2012-17900
    Event Type
    Injury
    Date Received
    September 13, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 22, 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 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 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 BY A BAXTER EMPLOYED HEALTH PROFESSIONAL FROM (B)(6) OF A HOME PATIENT (HP) THAT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE BY NOT WEARING A MASK DURING THERAPY AND NOT CLEANING AROUND THE AREA BEFORE STARTING PERITONEAL DIALYSIS (PD) WHICH LED TO PERITONITIS IN COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. DURING A CALL WITH BAXTER INDIA TECHNICAL SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE (ONSET DATES NOT REPORTED). ON AN UNREPORTED DATE, THE PATIENT WAS TREATED FOR PERITONITIS WITH VANCOMYCIN INJECTION (1G, IP ONCE IN 4 DAYS) AND FORTUM INJECTION (1G, IP FOR 14 DAYS NIGHT DWELL). NO ADDITIONAL INFORMATION IS AVAILABLE AS OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R DIANEAL PD2 (B)(4)