BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2584020 · Received May 22, 2012

    Report

    Report Number
    1423500-2012-10975
    Event Type
    Injury
    Date Received
    May 22, 2012
    Date of Event
    April 1, 2012
    Report Date
    May 1, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF DID NOT WEAR A MASK AND PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON (B)(6) 2012, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 (2.5% GLUCOSE) ULTRABAG (DOSE AND FREQUENCY NOT REPORTED, LOT NUMBER 1201059) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). THE ACTION TAKEN WITH DIANEAL THERAPY WAS REPORTED TO BE ONGOING. ON AN UNREPORTED DATE THE PATIENT DID NOT WEAR A MASK. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS REPORTED TO BE THE CLIENT DID NOT WEAR A MASK. ON AN UNREPORTED DATE THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2012 THE PATIENT WAS STARTED WITH TREATMENT OF AN INJECTION OF REFLIN (1GM, EVERY DAY, IP), INJECTION OF ORZID (1G, DAILY, IP), INJECTION OF VANCOMYCIN (1GM, STAT, IP) INJECTION OF AMIKACIN (100MG, EVERY DAY, IP) AND INJECTION OF HEPARIN (500 IU, THREE TIMES PER DAY, IP). AFTER CONFIRMATION FROM THE CLINICAL CO-ORDINATOR, IT WAS FOUND THAT THE RE-TRAINING HAD BEEN CARRIED OUT. THE PERITONITIS IS REPORTEDLY RESOLVING.

    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 50 YR Hospitalization| R DIANEAL PD2 ULTRABAG