BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUNNELL, INC.

    MDR report key: 4879065 · Received June 26, 2015

    Report

    Report Number
    1719232-2015-00004
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    May 14, 2015
    Report Date
    June 14, 2015
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED SYMPTOM THAT THE PATIENT CIRCUIT (LOT NUMBER 13065509) HUMIDIFIER CARTRIDGE OVERFILLED AND DELIVERED WATER TO THE PATIENT COULD NOT BE VERIFIED AND WAS NOT REPRODUCED. REPEATED DRAINING AND FILLING OF THE CARTRIDGE THROUGHOUT A 7 DAY CONTINUOUS OPERATIONAL TESTING PERIOD ALWAYS RESULTED IN CONSISTENT MID-LEVEL FILL AND PUMP INHIBIT OPERATION WITH NO OVERFILL CONDITION OBSERVED. NO OPERATIONAL ISSUES WERE OBSERVED WITH THIS PATIENT CIRCUIT FROM LOT NUMBER 13065509.

    Description of Event or Problem · 1

    AFTER A PATIENT WAS SET UP ON THE LIFE PULSE HFV THE PATIENT CIRCUIT HUMIDIFIER CARTRIDGE OVERFILLED, RESULTING IN WATER ENTERING THE TUBING AND REACHING THE BABY. THE BABY'S HEART RATE AND BLOOD OXYGENATION WENT DOWN. THE THERAPIST IMMEDIATELY DISCONNECTED, SUCTIONED, AND SUPPORTED THE PATIENT. THE CIRCUIT WAS CHANGED. THE NEW CIRCUIT FUNCTIONED NORMALLY. PATIENT WAS STABILIZED FOLLOWING CIRCUIT CHANGE AND RESTART OF LIFE PULSE. THE BUNNELL, INC. CLINICAL HOTLINE WAS NOT CALLED AT THE TIME OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415834 BUNNELL, INC. PATIENT CIRCUIT LSZ BUNNELL, INC. 00212 13065509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention