BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4252053 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40724
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER CASSETTE. (B)(6). 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 (APD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AN UNKNOWN MEDICATION (DOSE, ROUTE AND FREQUENCY NOT REPORTED) FOR THE EVENT. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT HAD RECOVERED FROM THE EVENT. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736616 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TITANIUM ADAPTER, MINICAP, HOMECHOICE| TRANSFER SET, DIANEAL