BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4180630 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36223
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. 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. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE, WHILE THE PATIENT WAS HOSPITALIZED FOR OTHER INDICATIONS, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNSPECIFIED DATE, DURING HOSPITALIZATION THE PATIENT WAS TREATED FOR THE PERITONITIS WITH UNKNOWN ANTIBIOTICS (DOSE, FREQUENCY, AND ROUTE WERE UNKNOWN). DURING HOSPITALIZATION, PD THERAPY WAS ONGOING WITH A HOMECHOICE DEVICE. IT WAS UNKNOWN IF THE PATIENT WAS USING HER OWN HOMECHOICE DEVICE OR THE FACILITY¿S DEVICE. ON AN UNREPORTED DATE, THE PERITONITIS WAS RESOLVED AND THE PATIENT WAS RECOVERED FROM THE PERITONITIS. SUBSEQUENT TO THE PERITONITIS EVENT, THE PATIENT PASSED AWAY DUE TO ANOTHER INDICATION AND IT WAS CONFIRMED THAT THE PATIENT HAD RECOVERED FROM THE PERITONITIS PRIOR TO DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662802 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD4, 2.5% AMBUFLEX, EXTRANEAL| CASSETTE, TITANIUM ADAPTER, MINICAP, HOMECHOICE