BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3151789 · Received June 7, 2013

    Report

    Report Number
    1416980-2013-14599
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE EXACT DATE OF THIS PERITONITIS EVENT IS UNKNOWN. HOWEVER, THE PATIENT EXPERIENCED PERITONITIS IN (B)(4) 2013. 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

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE DRUGS WERE WITHDRAWN. THE PATIENT WENT TO THE HOSPITAL FOR ABDOMINAL PAIN. THE SOLUTION COMING OUT OF THE PATIENT WAS DISCOLOURED AND CONTAINED FIBRIN. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS GIVEN UNSPECIFIED ANTIBIOTICS AND PAIN MEDICATION. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED, HE HAD NOT BEEN OUT OF BED YET. THE PATIENT'S SPOUSE STATED THEY HAVE NEVER HAD ANY PROBLEMS WITH THE SOLUTIONS. PERITONITIS DEVELOPED BECAUSE PATIENT'S BOWELS WERE WEAK AND HAD BOWELS RUPTURED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252799 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R DIANEAL PD4 1.5%, 2.5%, 4.25% AND EXTRANEAL 7.5%