BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3172576 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15514
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ABDOMINAL PAIN AND CLOUDY EFFLUENT AND WENT TO THE HOSPITAL. THE PATIENT BEGAN TREATMENT WITH CEFAZOLIN (1 GRAM (G), IP, EVERYDAY) AND CEFTAZIDIME (1G, IP, EVERYDAY) PER THE HOSPITAL'S PROTOCOL. THE PATIENT CONTINUED WITH CEFAZOLIN (1 G, IP, EVERYDAY). THE PATIENT'S SYMPTOMS WORSENED. THE PATIENT WAS MAINTAINED ON CEFAZOLIN AND BEGAN TREATMENT WITH VANCOMYCIN (1.5 G, IP, EVERY 5 DAYS). THE PATIENT'S CONDITION HAD NOT IMPROVED AND THE DECISION WAS MADE TO REMOVE THE PD CATHETER. ON AN UNREPORTED DATE, PD THERAPY WAS TEMPORARILY WITHDRAWN AND THE PATIENT BEGAN HEMODIALYSIS. THE PATIENT WAS STARTED ON AMPHOTERICIN B THERAPY (DOSE, ROUTE AND FREQUENCY NOT REPORTED). THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273218 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other B COMPLEX, PARICALCITOL, AMIODARONE,| FUROSEMIDE, ERYTHROPOIETIN AND CHOLECALCIFEROL.| UNKNOWN DIANEAL| ISOSORBIDE MONONITRATE, ACETYLSALICYLIC ACID,| PHYSIONEAL, EXTRANEAL, NUTRINEAL, FOLIC ACID,