BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4141122 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34463
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH A LOADING DOSE OF VANCOMYCIN (DOSE NOT REPORTED, INTRAPERITONEALLY, FREQUENCY AND DURATION NOT REPORTED) AND FORTEZ (1000 MG, INTRAPERITONEALLY, FREQUENCY NOT REPORTED, DURATION OF SEVEN DAYS) FOR THE PERITONITIS. THE PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL AND REPORTED TO HAVE RECOVERED FROM THE EVENT. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619127 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R EXTRANEAL VIAFLEX| HOMECHOICE| TRANSFER SET| MINICAP| CASSETTE| DIANEAL PD2 AMBUFLEX