BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4123591 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33520
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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 SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION GENTAMYCIN (INTRAPERITONEALLY, FOR 5 DAYS, DOSE AND FREQUENCY NOT REPORTED) AND CIPRO (ORALLY, DOSE, DURATION AND FREQUENCY NOT REPORTED) FOR PERITONITIS. THE PATIENT HAD RECOVERED FROM THE PERITONITIS EVENT AND SUBSEQUENTLY DIED DUE TO UNRELATED EVENTS. THE PD THERAPY WAS ONGOING DURING THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602299 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL 1.5% PD4 AMBUFLEX, HOMECHOICE| CASSETTE,TRANSFER SET, MINICAP| DIANEAL 1.5%, 2.5%, 4.25% ULTRABAG PD4