BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3841618 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17507
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    January 10, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL DISCOMFORT. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. ON THE SAME DAY AS THE ONSET OF PERITONITIS, THE PT WAS TREATED WITH VANCOMYCIN (2 GRAMS, STAT) IP AND GENTAMICIN (40MG, STAT) IP FOR PERITONITIS. THE PT RECOVERED FROM THIS PERITONITIS EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318702 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention DIANEAL 1.36%