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

Catalog Number MK06000

Device Problems Decrease in Pressure (1490); Use of Device Problem (1670); Inaccurate Delivery (2339); Gas/Air Leak (2946)

Patient Problems Bradycardia (1751); Respiratory Arrest (4461)

Event Date 06/23/2022

Event Type  Death  

Manufacturer Narrative

The investigation was just started.The result will be provided after closing the investigation.

Event Description

It was reported that device had a leak and failure during use.As further reported, the patient progressed to bradycardia and respiratory arrest.Reportedly the patient died after the surgery.Based on preliminary log analysis and based on the on-site checking in follow-up to the event, no indications for a device malfunction were found.A leakage at the soda lime does not affect automatic ventilation.The integrated pressure-, flow- and patient gas monitoring ensures that deviations from set/expected parameters are obvious and that alarms are given according to the alarm limits adjusted by the user.During system test and leak test, internal and external leakages are detected.During use, based on leakage, fresh gas flow settings and set alarm limits, several audible and visible alarms would be issued.The preliminary log analysis revealed that the device gave several alarms during the case to call the attention of the user.Nevertheless, a use error leading to the patient¿s death could not be fully excluded.

Manufacturer Narrative

Based on the logfile analysis, the case in question could be reconstructed and no indications for a device malfunction were found.During on-site checking in follow-up to the event by the dräger service, no device failures were found either.As further reported, the anaesthesiologist found a soda lime reservoir not being seated properly.After refitting the soda lime, the problems related to the leakage reportedly stopped.It was additionally reported that the reusable soda lime absorber was used and that the soda lime was replaced before the procedure in question.Based on the log analysis, the reported leakage at the co2 absorber during the case in question could be reconstructed.During system test and leak test, internal and external leakages are detected.During use, based on leakage, fresh gas flow settings and set alarm limits, several audible and visible alarms would be issued.The log analysis revealed that a system test was performed in the morning of the day in question.Since the soda lime was reportedly replaced prior to the procedure in question, which was the second case of that day, a leak test should have been performed by the user prior to starting that second case.The ifu describes that the leakage test needs to be performed after filling the co2 absorber.Thus, it can be stated that the leak at the absorber would have been detected by the device if the leak test had been initiated by the user.Just from the beginning of the case in question the device displayed - almost permanently - the alarm fresh gas low or leakage.However, a leakage at the absorber does not lead to an actual lack of fresh gas but to the pressure in the manual bag being below the limit and therefore triggering the alarm.A leak at the absorber does not lead to any restrictions of the automatic ventilation either and only, depending on the set fresh gas flow, to a contamination of the fresh gas with room air.But in addition to the leakage at the co2 absorber, log entries pointing to external leakages in the patient circuit leading to a temporary loss of pressure, volume and fresh gas were found as well.The device behaved as specified for the detected situation and alarmed inspiratory tidal volume high, peep/cpap low, apnea and fresh gas low or leakage accordingly.The log entries showed that after the user switched back and forth between man/spont and volume control af mode, ventilation finally went back to normal and stable values.Then again, approx.Three hours later during the case, a massive fresh gas deficit was present again resulting in multiple alarms (e.G.Apnea, fresh gas low or leakage, emergeny air inlet activated, minute volume low).Dräger finally concludes that there was no device malfunction found that contributed to the reported patient¿s death.A leakage at the co2 absorber could be reconstructed and also external leakages in the patient circuit were found.The integrated pressure-, flow- and patient gas monitoring ensures that deviations from set/expected parameters are obvious and that alarms are given according to the alarm limits adjusted by the user.The log analysis showed that the device reacted as specified upon the detected leaks and gave several alarms during the case to call the attention of the user.

Event Description

It was reported that device had a leak and failure during use.As further reported, the patient progressed to bradycardia and respiratory arrest.Reportedly the patient died after the surgery.Based on preliminary log analysis and based on the on-site checking in follow-up to the event, no indications for a device malfunction were found.A leakage at the soda lime does not affect automatic ventilation.The integrated pressure-, flow- and patient gas monitoring ensures that deviations from set/expected parameters are obvious and that alarms are given according to the alarm limits adjusted by the user.During system test and leak test, internal and external leakages are detected.During use, based on leakage, fresh gas flow settings and set alarm limits, several audible and visible alarms would be issued.The preliminary log analysis revealed that the device gave several alarms during the case to call the attention of the user.Nevertheless, a use error leading to the patient¿s death could not be fully excluded.

• 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
• MDR Report Key: 15037131
• MDR Text Key: 296040984
• Report Number: 9611500-2022-00171
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)171024(17)180531(93)MK06000-34
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• 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: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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): Death