BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2754457 · Received September 21, 2012

    Report

    Report Number
    1416980-2012-00320
    Event Type
    Injury
    Date Received
    September 21, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 31, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE IS UNKNOWN. 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 CAUSE COULD NOT BE DETERMINED, SINCE IT IS UNSURE WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. A LABELING REVIEW FOUND THE HOME CHOICE USER MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS BY A CONSUMER FROM (B)(6) OF PATIENT MADE A MISTAKE/BREAK IN ASEPTIC TECHNIQUE/DID NOT WEAR A MASK (CODED AS PERITONEAL DIALYSIS COMPLICATION) AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL 1.5% ULTRABAG (DIANEAL_1.5% PD2_SOLUTION FOR PERITONEAL DIALYSIS_BAG, PVC) THERAPY. ON (B)(6) 2012, THE PATIENT BEGAN TREATMENT WITH DIANEAL 1.5% ULTRABAG THERAPY (DOSE, FREQUENCY NOT REPORTED WITH LOT NUMBER 1203088) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. ON (B)(6) 2012, DURING A CALL WITH BAXTER INDIA TECHNICAL SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE MISTAKE AND DID NOT WEAR A MASK AND THERE WAS A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS PATIENT MADE MISTAKE/BREAK IN ASEPTIC TECHNIQUE/DID NOT WEAR A MASK. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION MEROPENEM 500MG/DAY AND INJECTION VANCOMYCIN 1GM/5TH DAY FOR PERITONITIS. IT WAS REPORTED THE PERITONITIS HAS RESOLVED (DATE NOT REPORTED).

    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 55 YR Required Intervention DIANEAL 1.5% PD2