BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4112299 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32958
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 THIS REPORT INVOLVES A PATIENT WHO EXPERIENCED CLOUDY EFFLUENT IN THE CONTEXT OF PERITONEAL DIALYSIS. WHILE THERE WAS NO PERITONITIS REPORTED, IT IS CURRENTLY UNABLE TO BE RULED OUT AS A CAUSE FOR THE REPORTED SYMPTOMS. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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 CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE CLOUDY EFFLUENT WAS UNKNOWN. TREATMENT FOR THE EVENT WAS NOT REPORTED. THE ACTION TAKEN WITH DIANEAL THERAPIES WAS UNKNOWN. THE PATIENT¿S OUTCOME WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592620 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization TRANSFER SET, MINICAP, DIANEAL