BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4090506 · Received September 15, 2014

    Report

    Report Number
    1416980-2014-31329
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    August 21, 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

    COMPLAINT NO: (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. 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. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED CLOUDY EFFLUENT AND SUSPECTED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED AND TREATED WITH UNSPECIFIED MEDICATION (DOSE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR CLOUDY EFFLUENT. THE OUTCOME OF THE EVENT IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569625 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R DIANEAL 1.5% SINGLEBAG, TRANSFET SET, MINICAP