BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 316895 · Received February 15, 2001

    Report

    Report Number
    1423500-2001-00126
    Event Type
    Malfunction
    Date Received
    February 15, 2001
    Date of Event
    January 20, 2001
    Report Date
    January 20, 2001
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PATIENT (HP) REPORTS THEY WERE CONNECTED TO HOMECHOICE DEVICE BEFORE THEY SHOULD HAVE BEEN, DURING PRIME. BAXTER TECHNICIAN ASSISTED HP IN CONTINUING TREATMENT FOR EVENING. NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF INCIDENT PER RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6072 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN