BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4123997 · Received September 27, 2014

    Report

    Report Number
    1416980-2014-33559
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 3, 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). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT REFERENCES THE SAME PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN THERAPY WITH INJECTION INTRAPERITONEALLY OF VANCOMYCIN 2GM, ONCE WEEKLY FOR TWO WEEKS AND INJECTION INTRAPERITONEALLY OF FORTUM 250MG IN EACH BAG, 3 EXCHANGES PER DAY FOR 14 DAYS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT THE OUTCOME OF THIS PERITONITIS EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603920 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention TRANSFER SET AND MINICAP| DIANEAL PD2 1.5% SOLUTION