BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3830751 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16843
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BAXTER HEALTHCARE-MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PERITONITIS EVENT OCCURRED ON AN UNSPECIFIED DATE IN APRIL 2014. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THIS REPORT REFERENCES THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND VOMITING. ON AN UNKNOWN DATE THE PATIENT WAS TREATED WITH UNSPECIFIED INTRAVENOUS (IV) ANTIBIOTICS, TWICE/DAY (DOSE AND DURATION NOT REPORTED). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNSPECIFIED DATE PD THERAPY WAS DISCONTINUED AND HEMODIALYSIS WAS INITIATED. AT THE TIME OF THIS REPORT THE PATIENT REMAINED HOSPITALIZED AND WAS RECOVERING FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308901 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE-MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOMECHOICE, MINICAP TRANSFER SET| DIANEAL LOW CALCIUM 2.5%, 4.25% AND EXTRANEAL