BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4052112 · Received September 2, 2014

    Report

    Report Number
    1416980-2014-29263
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER CASSETTE. 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. 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. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. TREATMENT, CAUSE AND OUTCOME FOR PERITONITIS WERE NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533324 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization TITANIUM ADAPTER, MINICAP| DIANEAL PD4 1.36%, HOMECHOICE, TRANSFER SET