BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3120811 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12968
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED FROM A NURSE: ON AN UNREPORTED DATE, THE PATIENT RESUMED EXTRANEAL THERAPY WITH NO ISSUES.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, EXTRANEAL THERAPY WAS DISCONTINUED. THE PATIENT EXPERIENCED PERITONITIS AND WAS TREATED WITH VANCOMYCIN. DURING THE TREATMENT WITH VANCOMYCIN, THE PATIENT DEVELOPED A RASH (DATE NOT REPORTED). IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. TREATMENT FOR THE RASH WAS NOT REPORTED. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222951 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTRANEAL