BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3123975 · Received May 22, 2013

    Report

    Report Number
    1416980-2013-13113
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FURTHER INFORMATION WAS RECEIVED FROM A NURSE. THIRTEEN DAYS AFTER HOSPITAL ADMISSION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM PERITONITIS. UPDATED WITH ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS AND TREATMENT RENDERED WAS NOT REPORTED. THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226138 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL PD4 1.5% AND 2.5%