BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 687437 · Received March 13, 2006

    Report

    Report Number
    1423500-2006-00362
    Event Type
    Malfunction
    Date Received
    March 13, 2006
    Date of Event
    February 8, 2006
    Report Date
    February 8, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT NEEDED HELP REPRIMING THE PATIENT LINE BECAUSE SHE HAD LEFT THE CLAMP CLOSED ON THE PATIENT LINE DURING PRIMING. THE TECHNICAL SERVICES REPRESENTATIVE HELPED THE PATIENT TO REPRIME THE PATIENT LINE USING THE REPRIME FEATURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AT THE TIME OF THE 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 CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR