BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2704698 · Received August 17, 2012

    Report

    Report Number
    1423500-2012-16242
    Event Type
    Injury
    Date Received
    August 17, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 26, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT ISSUE AND PERITONITIS. COMPLAINT IS CONFIRMED BECAUSE THE CUSTOMER REPORTED THEY REUSED THE SINGLE-USE SUPPLIES, WHICH IS A USE ERROR/POOR ASEPTIC TECHNIQUE. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED HEALTHCARE PROFESSIONAL FROM (B)(6) OF REUSED EQUIPMENT AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL ULTRABAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL 1.5% ULTRABAG, 2000ML, LOT NUMBER 1203030 AND DIANEAL 2.5% ULTRABAG, 2000ML, THERAPIES INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER INDIA TECHNICAL SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, EQUIPMENT WAS REUSED FOR THE PATIENT. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS REUSED EQUIPMENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH CEFTAZIDIME INJECTION 1GM, 2BAGS/DAY AND VANCOMYCIN INJECTION, 500MG, 1 BAG/3DAYS FOR PERITONITIS. THE PATIENT WAS STILL HOSPITALIZED. THE PATIENT IS RECOVERING.

    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 44 YR Hospitalization| R DIANEAL ULTRABAG 2.5% DEXTROSE| DIANEAL ULTRABAG 1.5% DEXTROSE