BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 228553 · Received June 17, 1999

    Report

    Report Number
    1423500-1999-00593
    Event Type
    Malfunction
    Date Received
    June 17, 1999
    Date of Event
    May 21, 1999
    Report Date
    May 21, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WIFE OF HOME PT (HP) REPORTS DISCONNECTING SOLUTION BAG ON HEATER LINE SPIKE OF HOMECHOICE SET AFTER RECEIVING "CHECK SUPPLY LINE" ALARM IN DRAIN 4/6. WIFE SPIKED NEW SOLUTION BAG ONTO HEART LINE SPIKE. HP THEN DISCONTINUED TREATMENT AND SET UP NEW SUPPLIES. HEALTHCARE PROFESSIONAL (HCP) REPORTS NO PT INJURY OR MEDICAL INTERVENTION AS A RESULT OF 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 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN