BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 675922 · Received February 6, 2006

    Report

    Report Number
    1423500-2006-00230
    Event Type
    Malfunction
    Date Received
    February 6, 2006
    Date of Event
    January 10, 2006
    Report Date
    January 10, 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

    A HOME PATIENT CALLED IN TO BAXTER'S TECHNICAL SERVICE CENTER AND REQUESTED ASSISTANCE RE-PRIMING THE PATIENT LINE USING THE HOMECHOICE SYSTEM. THE HOME PATIENT STATED CLAMP WAS CLOSED ON PATIENT LINE DURING PRIMING. BAXTER'S TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HOME PATIENT WITH RE-PRIMING. 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 FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR