BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4130806 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33956
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - CHANDLER
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FOLLOW UP WITH A PERITONEAL DIALYSIS REGISTERED NURSE, IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH INTRAPERITONEAL FORTAX (1300MG DAILY FOR FOURTEEN DAYS) FOR PERITONITIS. THE NEXT DAY, THE PATIENT WAS TREATED WITH INTRAPERITONEAL VANCOMYCIN (1000MG EVERY FIVE DAYS) FOR THE EVENT. NINETEEN DAYS LATER, TREATMENT WITH VANCOMYCIN WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. FURTHER FOLLOW UP WITH THE PATIENT IDENTIFIED THAT THE PATIENT WAS USING A PLASTIC ADAPTER (MANUFACTURER UNKNOWN) DURING THE ONSET OF PERITONITIS. AS A BAXTER TITANIUM ADAPTER WAS NOT BEING USED AT THE TIME THAT THE PERITONITIS OCCURRED, IT IS NO LONGER BEING CONSIDERED AS A SUSPECT PRODUCT FOR THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT EXPERIENCED PERITONITIS. 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. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS NOT REPORTED. IN THE SAME MONTH, THE PATIENT WAS HOSPITALIZED FOR THE EVENT FOR ONE NIGHT. THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS (DOSE, FREQUENCY AND ROUTE OF ADMINISTRATION NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM PERITONITIS. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607638 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CHANDLER

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL 1.5% SINGLEBAG, MINICAP AND TRANSFER SET