MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Catalog Number MK06000

Device Problem Misconnection (1399)

Patient Problems Pneumothorax (2012); Low Oxygen Saturation (2477); Cough (4457)

Event Date 02/25/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that after a successful removal of a foreign body the patient woke up before transfer to recovery and started coughing on the tube and began to have a mottled complexion.It was decided to put the patient back on the ventilator circle circuit.After a short time the anesthetic circuit popped off from the patients tube and the patient began to desaturate and was difficult to ventilate.A switch back to the t-piece and cylinder was performed.As the patient's oxygen saturation were between 74-88% an abcde approach was carried out.When checking the breathing circuits, it was identified that when reconnected, that one of the anesthetic circuit limbs had been attached incorrectly on the common gas outlet, which was immediately rectified.A chest x-ray revealed a bilateral pneumothorax which was solved by decompression of the lung.Finally, the patient was transferred to a picu centre.

Manufacturer Narrative

The electronic device log file was analyzed to reconstruct the reported event.On the reported date of event the february 25th 2023 the system test was passed in the morning.Directly before the case in question a leakage test was performed and passed.The procedure was started in man/spont mode and was continued in volume control mode after some seconds.The following ventilation was widely unremarkable and after 20 minutes the unit was placed in standby.34 seconds later a further therapy was started using man/spont.After 5 seconds the user switched over to the external outlet mode and increased the fresh gas flow to 15 l/min.As in ext.Outlet mode neither pressure nor volume monitoring is active, only the patient gas measurement was available.20 minutes later, the mode was changed to pressure control and back to man/spont while the device issued several alarms, e.G., apnea and minute volume low.After one hour the mode was switched back to pressure control and 2 hours later the device was placed in standby.The logfile review revealed no indications for any kind of technical malfunction of the device in question.It can be concluded that the reported symptom was the result of an user error.In case the expiratory tube is connected to the external fresh-gas outlet instead the expiratory port of the integrated breathing system, neither automatic nor manual/spontaneous ventilation is possible.Due to the resulting expiratory occlusion, a pressure release is not possible and the airway pressure increases continuously as reported.In external outlet mode pressure and volume monitoring are inactive, so that no pressure and/or volume related alarms were given.While in man/spont respectively pressure control the device issued appropriate volume related alarms indicating the disturbance of ventilation to the user.Due to the ¿open¿ expiratory port, airway pressure remained at 0, what is obvious to the user.The integrated patient gas monitoring further allows a permanent overview with respect to the ventilation performance and the patient condition.Due to e.G., an atypical etco2 curve an inadequate ventilation of the patient is clearly visible to the user and the inspiratory and exspiratory oxygen concentrations displayed gives information about the oxygenation of the patient and the o2 uptake.The instructions for use contain adequate instructions for assembly and preparation of the device prior to use.This includes notes as well as appropriate warnings with regard to the correct connection of the breathing circuit.Furthermore, the intended use of the external fresh gas outlet as well as the usage of non-rebreathing systems is described in detail.The external fresh gas outlet is an optional feature and positioned in physical distance to the integrated breathing system to avoid misconnections at best.The external fresh gas outlet ist designed in accordance with the relevant standards.It could be comprehended that before starting the second part of the procedure no leak test was performed as recommended after replacement or reconnection of the patient circuit.A faulty connection, as in the present case, would have been reliably detected with a system or leakage test.Finally, no indications for a device malfunction could be identified.The device behaved as specified.The outcome of the case in question was caused by user errors.

Event Description

It was reported that after a successful removal of a foreign body the patient woke up before transfer to recovery and started coughing on the tube and began to have a mottled complexion.It was decided to put the patient back on the ventilator circle circuit.After a short time the anesthetic circuit popped off from the patients tube and the patient began to desaturate and was difficult to ventilate.A switch back to the t-piece and cylinder was performed.As the patient's oxygen saturation were between 74-88% an abcde approach was carried out.When checking the breathing circuits, it was identified that when reconnected, that one of the anesthetic circuit limbs had been attached incorrectly on the common gas outlet, which was immediately rectified.A chest x-ray revealed a bileteral pneumothorax which was solved by decompression of the lung.Finally, the patient was transferred to a picu centre.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16544770
• MDR Text Key: 311303134
• Report Number: 9611500-2023-00097
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention