BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3241269 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19331
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT'S DATE OF BIRTH WAS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS BORN IN (B)(6). 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. THE SAMPLE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON THE DAY OF THE ONSET OF PERITONITIS, THE PATIENT WAS HOSPITALIZED. DURING HOSPITALIZATION, THE PATIENT WAS TREATED INEFFECTIVELY. TWO WEEKS AFTER BEING HOSPITALIZED, THE HP'S CATHETER WAS REMOVED IN ORDER TO TRANSFER THE HP TO HEMODIALYSIS THERAPY. AS A RESULT, THE DIANEAL THERAPY WAS DISCONTINUED. A MONTH AFTER BEING HOSPITALIZED, THE HP WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS NOT RECOVERED FROM PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340648 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 1.5%