BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4123982 · Received September 27, 2014

    Report

    Report Number
    1416980-2014-33561
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). THIS REPORT INVOLVES AN UNKNOWN BAXTER TITANIUM ADAPTOR 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 PATIENT WAS HOSPITALIZED FOR THE PERITONITIS ON AN UNKNOWN DATE IN THE SAME MONTH AS THE ONSET. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT DISCONTINUED PD THERAPY AND WAS TRANSFERRED TO AN IN-CENTER HEMODIALYSIS. HEMODIALYSIS WAS ONGOING AT THE TIME OF THIS REPORT. THE OUTCOME OF THE EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603834 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization TRANSFER SET, MINICAP, EXTRANEAL| DIANEAL PD4 2.5% AMBUFLEX AND ULTRABAG