MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC HEMOLUNG RAS

Device Problems Failure to Advance (2524); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported to alung that while on a patient, the controller rebooted itself.When the physician arrived, the controller was going through the self-checks, got to the final system check but physician could not advance the screen.The physician proceeded to switch the machine off and back on, it went through the re-booting sequence and presented failure code 24 - stuck button.Physician followed the instructions presented on the controller screen which did not correct the problem.The site followed the protocol, increased the vt to 6 ml/kg, removed the circuit, and therapy was terminated.Post 24 - stuck button error , as reported by the physician, indicates that one or more of the control buttons on the overlay appear to be pressed.This can be a result of the user holding buttons down while booting.It can also be a result of poor connections on the cable between the display and controller.If neither of those is the cause, then there is likely a hardware failure with the overlay.Avensy's serviced the controller at the site, and it passed all tests outlined in qsd 540-017.The service engineer noted that the function was checked, and he tightened cables between the screen and the main unit.Also, he was unable to replicate the fault.As such, no fault was found during servicing of controller.It is indicative that the error was caused by poor connections on the cable between the display and controller.Alung is taking the following actions: communicate to hospital to discontinue use of the device.Completed remove from the hospital for inspection and servicing.Completed.Continue discussions with the physician and hospital staff to determine if there is any additional information relevant to the case.Completed.Alung will collect the controller data log and analyze the system performance during the case therapy.Completed.Complete final analysis of the event.Completed.Alung's device analysis results: a review of the datalog was conducted by alung's engineering department.The case runs normally from 12/17/2018 until 12/21/2018.The pump rpm and sweep gas flow are gradually brought up to 1400 rpm and 10 l/min, respectively and remain at those levels until around 20:51 on 12/21/2018.At 20:51, the pump rpm is decreased from 1400 to 840 over about 15 seconds.About 15 seconds later at 20:51:51 the pump is stopped and logging stops for some unknown reason.Logging resumes at 21:06:47, and the controller is still in therapy state, it is running on battery and the sweep gas and blood pump are off.The hospital reported an error 24 after restarting the machine.The restart is not seen, and nor is there any record of a post error 24 occurring on startup.It is unknown what happened in the 15 minutes data is not logged.One would expect if it was restarted at this time that the cr3 would run post and then go into a start up state, but instead the controller is already in therapy state.Avensy's serviced the controller at the hospital, and it passed all tests outlined in qsd 540-017.The service engineer noted that the function was checked, and he tightened cables between the screen and the main unit.Also, he was unable to replicate the fault.As such, no fault was found during servicing of controller.It is indicative that the error was caused by poor connections on the cable between the display and controller; however this is unknown as the data log analysis does not support the claim of an error 24 occurrence.As previously stated, there is a 15 minute window in which logging of the controller is not captured so alung is unable to appropriately analyze and substantiate the hospital's sequence of reported event.As such, the controller was removed from the hospital and was returned to avensy's for further testing.The controller was tested yet again, and it passed all tests and was functioning as intended.However, this device will be returned to alung and will no longer be utilized in a clinical setting.Alung made this decision out of an abundance of caution since alung's internal investigation and analysis were inconclusive.It should be noted that the patient was successfully extubated and discharged from the ward.Hence, the device malfunction had no impact on the patient.No further actions concerning the device are required.(b)(4).

Event Description

Per the treating physician, while on a patient, the controller rebooted itself, when physician arrived at 13:05 it was going through the self-checks, got to the final system check but physician could not advance the screen.The physician proceeded to switch the controller off and back on, it went through the re-booting sequence and presented failure code 24 - stuck button.The advice on the screen was to switch the machine off and back on, and if the fault persist, call alung.Physician tried this twice, with no avail.The site followed the protocol, increased the vt to 6 ml/kg, removed the circuit, and therapy was terminated.There no harm to the patient reported.

• Brand Name: HEMOLUNG RAS
• Type of Device: HEMOLUNG RAS
• Manufacturer (Section D): ALUNG TECHNOLOGIES, INC; 2500 jane street; suite 1; pittsburgh PA 15203
• Manufacturer (Section G): ALUNG TECHNOLOGIES, INC; 2500 jane street; suite 1; pittsburgh PA 15203
• Manufacturer Contact: frank falcione ; 2500 jane street; suite 1; pittsburgh, PA 15203 ; 4126973370
• MDR Report Key: 8262294
• MDR Text Key: 135163260
• Report Number: 3009763347-2019-00001
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1