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 12/14/2021

Event Type  Injury  

Event Description

It was reported that when the patient was connected to the anesthesia workstation in manual ventilation mode, after pre-oxygenation with 100 % oxygen and intubation, the co2 was measured normally but the delivered tidal volume was low, <100 ml.The patient's saturation decreased briefly for about 2 minutes, the lowest measured oxygen saturation was 70%.The patient was disconnected from the anesthesia workstation and manually ventilated and the patient's saturation increased.The final patient outcome was no injury.Manufacturer's reference #: (b)(4).

Manufacturer Narrative

The investigation into this complaint has been completed.The investigation consists of received information and evaluation of the anesthesia system device log.The anesthesia system was tested by the hospital biomedical department.No fault was found and no parts were replaced.Evaluation of the device logs: the test log shows that a successful system checkout was performed prior to the event.The technical log has no entry that would indicate a technical failure in the system at the time of event.The trend log shows that co2 was measured and that there was a gas exchange (oxygen consumed) during the two first minutes when the patient was connected to the system.The measured inspiratory tidal volumes were about 80 ml.After the two first minutes the measured fio2 and eto2 were same and measured co2 was zero indicating that the patient was not connected.The event log shows that the treatment was in manual ventilation mode with the o2 concentration set to 100%, apl pressure set to 5 cmh2o and fresh gas flow set to first 8 l/min and then increased to 12.1 l/min.A few minutes after case start, the o2 flush button was pressed and 2 minutes later the apnea alarm was generated indicating that no breaths was measured.Soon after the apnea alarm, alarms for occlusion in sampling line, air gas supply pressure low and battery operation were generated which indicates that the patient had been disconnected from the system and the treatment was then ended.The logs show no indication of a technical failure or system malfunction at the time of the event.During manual ventilation mode the fresh gas flow is constant during both inspiration and expiration.The gas delivery is administrated to the patient by compression of the manual breathing bag.When the set apl (adjustable pressure limit) pressure is reached the apl valve relieves the patient circuit of excess pressure and ventilates the gas into the agss.With the apl set to 5 cmh2o the patient will be ventilated by each compression of the manual breathing bag up to 5 cmh2o pressure.Assuming that the airway interface is secured, the volume delivered to the patient is depending on a combination of the set apl pressure, fresh gas flow and the anesthesia providers bag compression rate.Our conclusion is that there were no technical system malfunctions at the time of the event.The most probable cause of the reported event was the low set apl pressure.

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: 13307081
• MDR Text Key: 284171517
• Report Number: 3013876692-2022-00005
• 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: Distributor
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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?: 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2022
• Distributor Facility Aware Date: 10/11/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2018
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening