BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4090734 · Received September 15, 2014

    Report

    Report Number
    1416980-2014-31384
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTOR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (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 REPORTED TO BE EITHER DUE TO THE DOCTOR NOT WEARING A MASK WHILE PERFORMING AN UNRELATED PROCEDURE OR THE PATIENT NOT FOLLOWING APPROPRIATE ASEPTIC TECHNIQUE; HOWEVER NEITHER OF THESE WAS MEDICALLY CONFIRMED. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. IT WAS REPORTED THAT THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. ON THE SAME DAY AS THE DIAGNOSIS OF THE EVENT, THE PATIENT WAS TREATED WITH FORTAZ INTRAPERITONEALLY (DOSE AND FREQUENCY NOT REPORTED) AND VANCOMYCIN INTRAPERITONEALLY (FOR 14 DAYS, DOSE NOT REPORTED) FOR THE EVENT. FORTAZ WAS DISCONTINUED FIVE DAYS AFTER STARTING ANTIBIOTIC THERAPY. IT WAS REPORTED THAT THE PATIENT WAS STARTED ON ANCEF INTRAPERITONEALLY (FOR 14 DAYS, DOSE NOT REPORTED). AT THE TIME OF THIS REPORT, ANTIBIOTIC THERAPY WAS ONGOING AND THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 4 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570216 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention DIANEAL, HOMECHOICE| TRANSFER SET, CASSETTE, MINICAP