BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4100761 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32140
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS ON AN UNREPORTED DATE TWO YEARS AGO. 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. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT¿S PD CATHETER WAS REMOVED AND THE PATIENT WAS PUT ON HEMODIALYSIS FOR THREE MONTHS PRIOR TO GOING BACK ON PD THERAPY. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 3 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582038 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention DIANEAL 1.5% AMBUFLEX, EXTRANEAL,| TRANSFER SET, CASSETTE, MINICAP, HOMECHOICE