BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG

    MDR report key: 171692 · Received May 10, 1998

    Report

    Report Number
    1423500-1998-01348
    Event Type
    Injury
    Date Received
    May 10, 1998
    Date of Event
    April 21, 1998
    Report Date
    April 27, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED A HOME PT REC'D A SYSTEM ERROR 2240 ALARM IN DRAIN 1/3 DURING TREATMENT USING HOMECHOICE DEVICE. THE HEALTHCARE PROFESSIONAL REPORTED THE PT LINE BECAME DISCONNECTED FROM THE TRANSFER SET. THE HEALTH CARE PROFESSIONAL NOTED THE HOME PT'S HUSBAND KEEPS THIS CONNECTION VERY LOOSE SO THE PT CAN UNHOOK HERSELF FROM HOMECHOICE ON HER OWN IN THE MORNING AND THE HUSBAND DOES NOT HAVE TO BE BOTHERED. THE HEALTH CARE PROFESSIONAL WILL F/U WITH THE PT'S HUSBAND. THE PT WAS HOSPITALIZED FOR 5 DAYS WITH PERITONITIS. THE PT WAS GIVEN ANCEF INTRAPERITONEALLY FOR 14 DAYS AND IS RESPONDING TO TREATMENT PER THE HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O