BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3202828 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-17066
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH CEFAZOLIN SODIUM, 4/1DAY IP (DOSE NOT REPORTED) THEN CHANGED TO MEROPENEM HYDRATE (2X 1/DAY IP, DOSE NOT REPORTED) FOR THE PERITONITIS. THE PATIENT DISCHARGED FROM THE HOSPITAL AND RECOVERED. FOUR DAYS AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT EXPERIENCED PERITONITIS BACTERIAL, MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. ON THE SAME DAY, THE PATIENT WAS READMITTED TO THE HOSPITAL. TREATMENT WITH MEROPENEM HYDRATE (2X 1/DAY IP, DOSE NOT REPORTED) TREATMENT WAS RESTARTED. THREE DAYS LATER, THIS TREATMENT WAS DISCONTINUED. ON AN UNREPORTED DATE IN (B)(6) 2013, THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS BACTERIAL AND WAS DISCHARGED FROM THE HOSPITAL. PD THERAPY WAS DISCONTINUED AND EVENTUALLY THE PATIENT CHANGED TO HEMODIALYSIS. THE RETRAINING OF PROPER CONNECT/DISCONNECT METHOD AND ASEPTIC TECHNIQUE WAS PERFORMED BY HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302450 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL