BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4251632 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40650
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT DEVELOPED PERITONITIS ON AN UNSPECIFIED DATE IN (B)(6) 2014. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTOR. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS TREATED WITH VANCOMYCIN INTRAPERITONEALLY (IP) (500MG DAILY) AND FORTAZ (CEFTAZIDIME) IP (1G DAILY) FOR THE EVENT. AT THE TIME OF THIS REPORT, ANTIBIOTIC TREATMENT WAS ONGOING AND THE PATIENT WAS RECOVERING FROM THE EVENT. DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 3 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737217 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

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