BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4140831 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34423
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (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 EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER EVALUATION, IT WAS DETERMINED THAT THE PATIENT WAS USING A PLASTIC ADAPTOR AT THE TIME OF THE PERITONITIS EVENT. THIS PRODUCT IS NOT MANUFACTURED BY BAXTER. AS A RESULT, THE BAXTER TITANIUM ADAPTER IS NO LONGER A SUSPECT PRODUCT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN AND THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH CEFACIDALE AND GENTAMYCIN (DOSE, ROUTES, FREQUENCIES, AND DURATIONS NOT REPORTED) FOR THE PERITONITIS. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. ACTION TAKEN WITH PERITONEAL DIALYSIS THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619642 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention TRANSFER SET, MINICAP| COVIDIEN PLASTIC ADAPTER| 55 C DIALYSE SOL