BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U0707 TINA SINGLE PUMP NIBPLCD

    MDR report key: 1994011 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02057
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDI
    PMA / PMN Number
    K970446
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. THE EVALUATION RESULTS INDICATE: THE DEVICE WAS EVALUATED AND NO DEVICE DEFECT WAS CONFIRMED. NO ISSUES OR DEFECTS WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE ASSIGNABLE CAUSE IS UNDETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A NURSE FROM (B)(6) REPORTED THAT DURING THE THIRD HOUR OF THERAPY WITH A TINA SINGLE PUMP DEVICE, THE PATIENT STARTED TO FEEL DIZZY AND PRESENTED HYPOTENSION. THE DEVICE SHOWED BLOOD PRESSURE AND TRANS-MEMBRANE PRESSURE ELEVATION. THE PATIENT ENDED THE THERAPY WEIGHING (B)(6) UNDER WHAT WAS INITIALLY PROGRAMMED. IT WAS REPORTED THAT THE DEVICE WAS EVALUATED BY TECHNICAL SERVICES AND NO FAILURE HAS BEEN EVIDENCED SO FAR. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2011: THE PATIENT IS IN GOOD HEALTH CONDITION AND RECOVERED FROM THE EVENT. NO MEDICAL INTERVENTION WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0707 TINA SINGLE PUMP NIBPLCD DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4)| FILTER (B)(4)| (B)(4)