BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT

    MDR report key: 163080 · Received April 17, 1998

    Report

    Report Number
    1423500-1998-01245
    Event Type
    Injury
    Date Received
    April 17, 1998
    Date of Event
    March 19, 1998
    Report Date
    March 19, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS HOMEPATIENT USING HOMECHOICE CYCLER FOR AUTOMATED PERITONEAL DIALYSIS THERAPY WAS DIAGNOSED WITH PERITONITIS. ON 3/19/1998, HOME PT PRESENTED TO EMERGENCY ROOM AT HOSP AND WAS GIVEN ANTIBIOTICS, HOME PT WAS NOT ADMITTED TO HOSP BUT RETURNED HOME SAME NIGHT ON 3/19/1998. HOME PT WAS TREATED WITH ANTIBIOTICS FOR 10 DAYS. HEALTHCARE PROFESSIONAL STATES THAT CAUSE OF PERITONITIS EVENT WAS UNABLE TO BE DETERMINED AND EVENT HAS SINCE BEEN RESOLVED. HEALTHCARE PROFESSIONAL INDICATED NO PRODUCT FAILURE OCCURRED AND SHE DID NOT FEEL HOME PT TECHNIQUE WAS THE CAUSE OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT HOMECHOICE FKX BAXTER HEALTHCARE CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other