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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS Back to Search Results
Catalog Number K042607
Device Problems Gas Output Problem (1266); Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2022
Event Type  Injury  
Event Description
It was reported that during a surgery the anesthesia machine began to fail in the mixture of fresh gases.The device was exchanged for another one, making it possible to complete the surgery.A maneuver was performed and drugs were applied to stabilize the patient.
 
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
 
Event Description
It was reported that during a surgery the anesthesia machine began to fail in the mixture of fresh gases.The device was exchanged for another one, making it possible to complete the surgery.A maneuver was performed and drugs were applied to stabilize the patient.
 
Manufacturer Narrative
The case in question was reconstructed based on the log analysis.The procedure was started on (b)(6) 2022 at 06:03pm, using man/spont and continued in volume mode from 06:09pm.The following ventilation was largely unremarkable and stable.At 00:47am, the gas mixer detected a too high mix gas flow compared with user settings.In the following two warm starts of the gas mixer have been performed to restore mixer functionality to no avail.Finally, the gas mixer changed to the safety mode and the corresponding "gas mixer fail" alarm was given.Based on the log entries the device reacted as specified upon the detected deviation.In case of a gas mixer failure, the fresh gas flow delivery via the electronic gas mixer is stopped.User is advised to set an adequate o2 safety flow and check vaporizer settings.The current ventilation mode remains active and available.Monitoring functions remain unaffected, thus the user is continuously informed about ventilation performance and patient gas measurement.It is comprehensible from the logs that the user opened the safety o2 valve to provide a sufficient flow as described above.Before occurrence of the mixer failure the fio2 value was ~45% and increased to approximately 75% after activation of the safety o2 valve.The current ventilation mode remained active as specified and the tidal volumes and pressure levels (incl.Peep) remained unchanged when comparing the values before and after the event.At 1:00am the unit was placed in standby.It can be concluded that the failure of the gas mixer had no effect on the ventilation or its parameter and accordingly could not have any influence on the patient status and therefore could not have contributed to the reported adverse event.As the gas mixer was switched off due to a deviation in the mixed gas flow in general the valve for the dosage of the mixed gas, the tank pressure sensor, the pressure sensors to determine the mixed gas flow or a leakage at the vaporizer interface can be considered as possible causes.It was recommended to replace the mentioned pressure sensors for the mixed gas flow determination and the mix gas flow valve.Since then no further feedback was received from customer site.Therefore, the exact cause could not be determined.The investigation revealed that neither the ventilation was stopped nor the ventilation parameters were changed due to the failure.The device behaved as specified upon a detected deviation just as the user has behaved as described in the ifu and as indicated by the device.A causal or contributing connection between the mixer failure and the patient¿s outcome could not be confirmed.The case was assessed as not reportable, in retrospect.
 
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Brand Name
PRIMUS
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 Key14571879
MDR Text Key293379112
Report Number9611500-2022-00130
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042607
Number of Events Reported1
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 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberK042607
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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