BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4121604 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33349
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH INJECTION OF REFLIN 1 GRAM PER DAY (ROUTE AND DURATION NOT REPORTED), INJECTION OF TOBRAMYCIN 40 MG PER DAY (ROUTE AND DURATION NOT REPORTED) AND INJECTION OF HEPARIN 25000 INTERNATIONAL UNITS (IU) X 5 ML THREE TIMES/DAY (ROUTE AND DURATION NOT REPORTED). DIANEAL THERAPY WAS ONGOING. 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 PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601951 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention DIANEAL PD2 2.5% SOLUTIONS, TRANSFER SET, MINICAP