BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3103322 · Received May 9, 2013

    Report

    Report Number
    1416980-2013-11882
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THREE DAYS AFTER THE CONFIRMED DIAGNOSIS OF PERITONITIS, THE PATIENT RECOVERED FROM THE PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).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 RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT THERAPY FOR PERITONEAL DIALYSIS (PD). THERAPY WAS PERMANENTLY WITHDRAWN. THE PATIENT EXPERIENCED ABDOMINAL PAIN AND A FEVER AS A RESULT OF THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. NO TREATMENT INFORMATION WAS PROVIDED. IT WAS NOT REPORTED IF THE PATIENT REMAINED HOSPITALIZED. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203836 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL