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

Model Number FLOW-I C30

Device Problem Output Problem (3005)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/01/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with the oxygen delivery to the patient.The patient saturation level decreased to 85%.The final patient outcome was no injury.Manufacturer's reference #: (b)(4).

Manufacturer Narrative

The investigation of this complaint has been completed.The anesthesia system was investigated by the hospital staff.No fault was found, and no parts were replaced.The anesthesia system has been returned for clinical use without further issues reported.The anesthesia system device logs were saved and sent for evaluation.According to received information from the hospital staff, the event occurred during ongoing anesthesia and in connection with the awakening of a child.The system had been switched to manual ventilation mode.It was stated that there were problems with the oxygen delivery and the fio2 suddenly dropped.An error message appeared on the monitor, but they had not time to read it completely because it was during the awakening phase and the patient's oxygen saturation dropped to 85%.In connection with this there was a sound like a bang from the system and thereafter, it appears that the anesthesia system delivered oxygen again.The patient oxygen saturation rose quickly to 100%.Evaluation of the received device logs for the time of the event shows that the system checkout prior to and after the event were successfully performed.The log shows that the treatment was started in manual ventilation and thereafter switched to automatic ventilation in pressure control.No agent was set or used during the treatment.Treatment was ongoing for 40 minutes, with only a few clinical alarms generated.After 40 minutes, the system was switched to manual ventilation with apl set to sp.After about 0.5 minute in manual ventilation, alarms for fio2 low were generated (lower alarm limit for fio2 were set to 30%) and 20 seconds later the safety flush was activated.The apl was increased to 22 cmh2o for one minute and thereafter set back to sp.The ventilation continued with a few more alarms for fio2 low and thereafter the system was set to standby.The displayed measured values in the trend log are an average of the measured values for one minute.The log shows that at the time when the ventilation was switched to manual ventilation the measured pressure, volume and respiratory rate decreased.The pressure decreased from 13 to 3.4 cmh2o, measured volume decreased from 2.8 l/min (tv about 125 ml) to 0.3 l/min (tv about 28 ml), measured respiratory rate decreased from 23 b/min to 8 b/min and measured fio2 decreased from 39 % to 34.About the time when the apl was increased the measured pressure, minute volume, respiratory rate and o2 concentration increased.The technical log shows that the only entry on the given date of event is when the safety flush was activated.With the apl set to sp, the manual breathing bag is being filled up to approximately 2 cmh2o pressure and almost all fresh gas will go to evac and not to the patient.The safety flush is activated to prevent the oxygen concentration in the breathing circuit from becoming too low and is only activated after the trigger requirements have been met for more than 20 consecutive seconds.When the system performs a safety flush the entire breathing circuit volume is replaced with gas containing a high oxygen concentration.The evaluation of the logs show no indication of a technical failure in the system at the time of the event.The issue with the reported oxygen delivery was most probable due to the low set apl pressure (sp) leading to a low tidal/minute volume to the patient.Even though the fresh gas contains a high o2 concentration, only a limited amount of the fresh gas will reach the patient every breath when the apl is set to sp.The cause of the reported sound like a bang in the system has not been determined.Our conclusion, based on the received information from the user facility that no fault was found, that the system is back in clinical use without further issues and the result from the system device log evaluation, is that there was no technical malfunction is the system that caused the reported 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: 17125105
• MDR Text Key: 317130989
• Report Number: 8010042-2023-01124
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening