MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR

Model Number 203

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

The user facility has indicated that the ventilator system would not be returned for evaluation.When the lifepulse humidifier is placed in wait mode the ventilator continues to provide breaths to the patient while the humidifier's functions (heating and humidifying the gas) are stopped.Therefore, if the cartridge door is opened in wait, and water enters the patient circuit, subsequent breaths may result in water being delivered to the patient.Placing the system into standby stops both the humidifier and ventilator functions.Additionally, the water level within the cartridge is clearly visible through the slots in the cartridge door; therefore, the user would be able to assess the water level before attempting to open the cartridge door.The user should take care to avoid water entering the patient circuit tubing if the cartridge door is opened with excessive water in the cartridge.If the water level is actually high, opening the cartridge door while the ventilator is running would be ill advised.Initial event report indicated that the respiratory therapist consulted the "quick reference guide" for the lifepulse high frequency ventilator, which told them to "place the humidifier in wait mode and open the cartridge door"; however, the bunnell quick reference guide does not mention placing the humidifier in wait mode and opening the cartridge door, in response to a circuit high level alarm.It was determined that, if the quick reference guide was followed, the user would have been directed to change the patient circuit (which requires placing the unit into standby, not wait) and then to call the bunnell hotline if the alarm persists.Upon further investigation into the device manuals and labeling, the following was determined: the operator's manual troubleshooting guide states that, in the event of a high water level alarm, the user should "place life pulse in standby mode and support patient.Remove cartridge/circuit and dump out excess water through green gas inlet tube.Re-install circuit making sure to install water inlet tube in pump housing, latching pump door securely.After making all appropriate connections restart life pulse by pressing enter button." if this does not clear the alarm the user is instructed to call the bunnell hotline.The lifepulse high frequency ventilator in-service manual states that, in the event of a high water level alarm, "the cartridge may need to be replaced".The manual also states that "a level high alarm rarely occurs but may be caused by a faulty humidifier cartridge.Replacing the cartridge/circuit usually eliminates this alarm." instructions on replacing the patient circuit are also provided, which instruct the user to place the system in standby while replacing the circuit.The alarms and advanced troubleshooting guide states that, in the event of a high water level alarm, the user should "place the humidifier in wait mode.Open the cartridge door and check the spring loaded contact pins.If the alarm persists, press the standby button and replace the humidifier cartridge/circuit." it should be noted that these instructions do not state that the user should touch the cartridge while the humidifier is in wait mode.Based on the details of the reported event, it is likely that the user was referring to the alarms and advanced troubleshooting guide, rather than the quick reference guide.All manuals do indicate that the user should consider calling the bunnell hotline if any alarm condition is not readily corrected.However, the instructions provided in the alarms and advanced troubleshooting guide would lead a user to respond as indicated in the user's report to a high water level alarm.This troubleshooting guide is currently being reviewed for possible update.An internal review of the setup of the lifepulse high frequency ventilator system was conducted.It was determined that if the user has set up the system correctly and does not move the cartridge it would be extremely unlikely that water will enter the patient circuit tubing while the cartridge door is open.However, if the user takes the cartridge out or tilts the ventilator itself (neither of these actions would be advisable, nor are they included in the instructions) it would be possible for water to enter the tubing.Additionally, it would be possible for water to enter the circuit if the user set the system up incorrectly such that the water inlet tubing did not pass through the water pump.This would allow water to enter the cartridge due to gravity, without the control the pump provides.While the alarms and advanced troubleshooting guide may need to be reviewed and potentially updated, it is likely that user error and/or failure to follow instructions contributed to this event.Device not returned for evaluation.

Event Description

The ventilator was running on a baby.A high level circuit fault alarm occurred.The therapist stated that they consulted the quick reference guide and followed the directions provided by placing the humidifier in wait mode and opening cartridge door.The ventilator was not placed in standby.As the cartridge door opened, water sloshed from the cartridge into the patient circuit and water was delivered to the baby via the circuit.The baby subsequently developed right-sided pneumonia.The patient was not being supported on the lifepulse ventilator at the time they developed pneumonia.

• Brand Name: BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR
• Type of Device: LIFEPULSE HIGH FREQUENCY VENTILATOR
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• Manufacturer (Section G): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• Manufacturer Contact: curtis olsen ; 436 lawndale drive; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 5681936
• MDR Text Key: 45997609
• Report Number: 1719232-2016-00001
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Respiratory Therapist
• Device Model Number: 203
• Device Catalogue Number: 203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/1992
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention