MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I; GAS-MACHINE, ANESTHESIA

Model Number FLOW-I C20

Device Problem Output Problem (3005)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 05/02/2023

Event Type  Injury  

Event Description

It was reported that while the anesthesia system was connected to a patient, the patient woke up.There was no sevoflurane administrated.According to received information, the vaporizer lid was open.The vaporizer lid was then closed by the user and the procedure continued.The final patient outcome is unknown.Manufacturer's reference #: (b)(4).

Manufacturer Narrative

The investigation of this complaint has been finalized.The system was investigated by the hospital staff after the event.No fault was found, and no parts were replaced.The system device logs were saved and sent for evaluation.Information received from hospital staff states that a message indicating that the vaporizer lid was open was displayed on the user interface.Evaluation of the system device log shows that a successful system checkout was performed prior to the treatment start.The treatment was started in manual ventilation mode and selected vaporizer was set to vaporizer 1.The agent concentration was set to off.One minute after treatment start the vaporizer lid was opened.The ventilation mode was set to automatic ventilation in volume control and after 48 seconds an agent concentration was set.The vaporizer lid was closed one hour and 45 minutes later.The treatment continued until the system was set to standby 5 hours later.During these hours a few agent concentration changes were performed, and the vaporizer lid was opened and closed on two occasions.A successful system checkout was performed the day after the event date.The system has according to the logs, continuously been used for treatment during the following 8 days until the system device logs were saved.There are no recordings of technical malfunctions in the technical log.The evaluation of the logs shows that there was no technical failure in the system at the time of the event.The vaporizer lid is opened when the vaporizer needs to be refilled.When the vaporizer lid is opened on an active vaporizer the vaporizer is depressurized and no agent is delivered.The agent concentration touch pad on the user interface is grayed out and cannot be selected when the lid is open.A system message stating ¿vaporizer lid open¿ is displayed in the system message area of the user interface until the lid is closed.There is also a pop-up window that appear on the user interface after 2 minutes if the vaporizer lid has been open more than 2 minutes.The pop-up window disappears from the user interface when "ok" in the pop-up window is pressed.When the system is set to automatic ventilation and if no agent concentration is set, a pop-up dialog reminding the operator to set an agent concentration is shown after 30 seconds.The pop-up window disappears from the user interface when "ok" in the pop-up window is pressed or an agent concentration is set.The conclusion is that there was no system malfunction at the time of the event.The cause of that no agent was delivered for 1 hour and 45 minutes due to the vaporizer lid open was a use error.By design, the user is notified by a message and a pop-up window that the vaporizer lid is open.The system has detected and correctly notified the user during the event.

Event Description

Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 17008455
• MDR Text Key: 315994761
• Report Number: 8010042-2023-00989
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C20
• Device Catalogue Number: 6888520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female