BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2944276 · Received February 5, 2013

    Report

    Report Number
    1416980-2013-02977
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. 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. THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS IS CONFIRMED BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE, DESCRIBED AS AREA NOT CLEAN BEFORE STARTING PERITONEAL DIALYSIS AND REUSED EQUIPMENT, WHICH CAUSED PERITONITIS; HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED SINCE IT IS UNCERTAIN WHY THE PATIENT HAD A 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. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A BAXTER EMPLOYED HEALTHCARE PROFESSIONAL FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG 2.5% THERAPY FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE, FURTHER DESCRIBED AS AREA NOT CLEAN BEFORE STARTING PERITONEAL DIALYSIS AND REUSED EQUIPMENT. ON (B)(6) 2013, THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION (INJ) VANCOMYCIN (2GM, WEEKLY ONCE FOR TWO WEEKS, INTRA-PERITONEALLY (IP)) AND INJ FORTUM (250MG, 3 EXCHANGES PER DAY FOR 14 DAYS, IP). THE OUTCOME OF THIS PERITONITIS EVENT IS UNKNOWN. THE STATUS OF RETRAINING WAS NOT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47946 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R DIANEAL PD2 2.5% ULTRABAG