BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U1105 S1000 TINA HD WITH NIBP

    MDR report key: 1914801 · Received December 4, 2010

    Report

    Report Number
    1423500-2010-06528
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDI
    PMA / PMN Number
    K970446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL TINA DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF THE DEVICE DELIVERING TOO MUCH HEPARIN WAS NOT CONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED DUE TO THE TECHNICIAN NOT BEING ABLE TO REPRODUCE THE PROBLEM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) PRODUCT SURVEILLANCE TO REPORT THAT THE TINA HEMODIALYSIS MACHINE HAD DELIVERED TOO MUCH HEPARIN. THE FIELD SERVICE TECHNICIAN MADE ARRANGEMENTS TO GO ONSITE TO EVALUATE THE DEVICE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO BAXTER FOR EVALUATION. THE PROCESS STEP AND ANY REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U1105 S1000 TINA HD WITH NIBP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1