BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TINA SYSTEM 1000 MACHINE USED - EXCELLENT CONDITION

    MDR report key: 1346472 · Received March 17, 2009

    Report

    Report Number
    1423500-2009-00142
    Event Type
    Injury
    Date Received
    March 17, 2009
    Date of Event
    February 23, 2009
    Report Date
    February 25, 2009
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKP
    PMA / PMN Number
    K910215
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON SITE VISIT WAS CONDUCTED IN 2009. THE EVALUATION RESULTS ARE PENDING.

    Description of Event or Problem · 1

    THE FACILITY NURSE REPORTED A PT EXPERIENCED COUGH AND TIGHTNESS IN THE CHEST DURING HEMODIALYSIS THERAPY ON THE TINA 1000 MACHINE. POSSIBLE AIR EMBOLISM WAS CONSIDERED. OXYGEN (LITER FLOW RATE UNKNOWN) WAS APPLIED AND AFTER 15 MINS, THE PT'S SYMPTOMS RESOLVED. THE PT FINISHED THE HEMODIALYSIS THERAPY SUCCESSFULLY. NO OTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TINA SYSTEM 1000 MACHINE USED - EXCELLENT CONDITION 78FKP FKP BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention