BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3972666 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-24973
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT HAD RECOVERED FROM THE PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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 EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE RECEIPT OF THIS REPORT, THE PATIENT STARTED TREATMENT FOR THE PERITONITIS WITH INJECTION (INJ.) MEROPENEM, 1GM/1 DAY AND INJ. VANCOMYCIN, 1GM/ EVERY FIFTH DAY INTRAPERITONEALLY. IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451197 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention DIANEAL 1.5% ULTRABAG