BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3073677 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10178
    Event Type
    Death
    Date Received
    April 23, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. 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. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT ACQUIRED PERITONITIS AND SUBSEQUENTLY PASSED AWAY. WHEN THE PATIENT WAS GETTING READY TO CONNECT TO THE PERITONEAL DIALYSIS (PD) DISPOSABLES TO PERFORM PD THERAPY, THE PATIENT DID NOT MAKE A SECURE CONNECTION FROM HIS PATIENT LINE TO HIS TRANSFER SET RESULTING IN THE PATIENTS LINE DROPPING ON THE FLOOR. THE PATIENT THEN PICKED UP THE PATIENT LINE AND RECONNECTED TO THE TRANSFER SET. THE PATIENT PRESENTED TO THE PD CLINIC WITH CLOUDY PD EFFLUENT. THE PD NURSE RETRAINED THE PATIENT ON PROPER ASEPTIC TECHNIQUE. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL. THE PATIENT WAS BEING TREATED AT HOME WITH INTRAPERITONEAL (IP) ANTIBIOTICS GENTAMYCIN AND VANCOMYCIN (DOSE AND FREQUENCY UNKNOWN). AFTER A FEW DAYS OF BEING TREATED WITH ANTIBIOTICS, THE PD NURSE STATED THE PATIENT'S PD EFFLUENT BECAME CLEAR. PD THERAPY WAS ONGOING AND THE PATIENT WAS CONSIDERED TO BE IN THE RECOVERY STAGES FROM PERITONITIS. AN UNKNOWN TIME LATER, IT WAS REPORTED THE PATIENT PASSED AWAY AT HOME, CONNECTED TO THE HOMECHOICE DEVICE. THE PATIENT HAD JUST BEGUN PD THERAPY A HALF HOUR PRIOR TO DYING. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174418 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R DIANEAL