BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4202982 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37548
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH UNSPECIFIED ANTIBIOTICS. AFTER TEN DAYS, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. APD THERAPY HAS SINCE BEEN DISCONTINUED AND THE PATIENT WAS PLACED ON HEMODIALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682681 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG| TRANSFER SET, CASSETTE, MINICAP, HOMECHOICE