BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2970556 · Received February 20, 2013

    Report

    Report Number
    1416980-2013-04289
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWELVE DAYS PRIOR TO THE REPORT, THE PATIENT FELL. TWO DAYS LATER, THE PATIENT WAS DIAGNOSED WITH SEPSIS AND WAS HOSPITALIZED THE SAME DAY. THE NURSE CONFIRMED THE SOURCE OF THE SEPSIS WAS THE PERITONITIS WHICH WAS CAUSED BY THE DISCONNECTION OF THE PATIENT'S TRANSFER SET AND SUBSEQUENT RECONNECTION OF THE TRANSFER SET TO THE ADAPTER BY THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. HOWEVER, THIS CONDITION WAS CONFIRMED, AS THE NURSE REPORTED A BREACH IN ASEPTIC TECHNIQUE. THE BREACH OCCURRED WHEN THE TRANSFER SET BECAME DISCONNECTED AND WAS THEN RECONNECTED BY THE HOME PATIENT. THE CAUSE WAS DETERMINED TO BE A USE ERROR, BASED ON THE BREACH IN ASEPTIC TECHNIQUE. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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. 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

    (B)(4). IT WAS REPORTED THAT A PATIENT DEVELOPED PERITONITIS AND SEPSIS FROM A BREAK IN ASEPTIC TECHNIQUE, DURING PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT HAD FALLEN, DUE TO WEAKNESS AND SEPSIS, AND WAS HOSPITALIZED THE NEXT DAY. THE SEPSIS WAS DETERMINED TO BE PERITONITIS, FROM A BREACH IN ASEPTIC TECHNIQUE. THE BREACH IN ASEPTIC TECHNIQUE OCCURRED FROM A DISCONNECTION OF THE PATIENT'S TRANSFER SET. THE PERITONEAL DIALYSIS NURSE (PDN) CONFIRMED THAT THE PATIENT WAS RECOVERING AND WAS BEING TREATED WITH AN UNKNOWN ANTIBIOTIC. AT THE TIME OF THIS REPORT, THE PATIENT HAS RECOVERED FROM THE EVENTS AND HAD BEEN DISCHARGED FROM THE HOSPITAL (DATES UNSPECIFIED). THE PDN REPORTED THAT THE PATIENT WAS NOT RE-TRAINED IN PROPER ASEPTIC TECHNIQUE FOLLOWING THESE EVENTS AND THAT THE PATIENT WAS SWITCHED TO HEMODIALYSIS (DATE UNSPECIFIED). AT THE TIME OF THIS REPORT, HD WAS ONGOING. THIS REPORT IS REPORT 1 OF 3 TOTAL REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75022 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R DIANEAL PD4, 1.5% ULTRABAG