BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4201441 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37429
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES AN UNKNOWN BAXTER TRANSFER SET. ADDITIONAL INFORMATION: ON AN UNREPORTED DATE IN (B)(6) 2014, THE PATIENT EXPERIENCED PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT RECEIVED UNREPORTED TREATMENT FOR THE PERITONITIS. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. ON AN UNREPORTED DATE, DIANEAL THERAPIES WERE WITHDRAWN AND HEMODIALYSIS WAS STARTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683438 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD4 1.5%, 2.5% AND 4.25 % SINGLEBAG| TITANIUM ADAPTER, MINICAP, CASSETTE, DIANEAL