BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 233281 · Received July 20, 1999

    Report

    Report Number
    1423500-1999-00779
    Event Type
    Malfunction
    Date Received
    July 20, 1999
    Date of Event
    June 22, 1999
    Report Date
    June 22, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PATIENT (HP) REPORTS LEAK IN CASSETTE OF HOMECHOICE SET IN DWELL, FOLLOWING A SYSTEM ERROR 2240 ALARM, WHEN FLUID WAS NOTED ON FLOOR. RN REPORTS HP NOTED HOMECHOICE SET LEAKED INSIDE THE DOOR OF HOMECHOICE DEVICE. HOMECHOICE DEVICE WAS SWAPPED AND SAMPLE OF HOMECHOICE SET WAS DISCARDED. PER RN, HP'S TRANSFER SET WAS CHANGED THE FOLLOWING MORNING, AND HP WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS: 2 GMS VANCOMYCIN X 1 AND 40 MGS TOBRAMYCIN X 1. RN RPTD NO HP INJURY RESULTING FROM INCIDENT.

    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 H99D30555

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN