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

Catalog Number 8603800

Device Problems Complete Blockage (1094); Gas Output Problem (1266); Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 05/30/2023

Event Type  Death  

Event Description

On (b)(6) 2023 it was reported to a draeger technician that an event occurred with a draeger infinity delta patient monitor mounted to a draeger primus anesthesia workstation where it was reported that the monitor did not alarm and the involved patient died.The customer is not providing further information until their internal investigation is completed.On (b)(6) 2023 dräger received a user facility report regarding the event in which ventilation problems during a surgery performed with a combination of a dräger primus anesthesia workstation and a dräger delta patient monitoring system were mentioned.As further information is not currently available, we are considering the allegation to be against both the primus and the delta.Remark: since the product responsibility for the used devices is with two different manufacturing sites in the dräger organization, two files for the documentation of investigation have been opened: internal reference # (b)(4) for the primus anesthesia workstation and # (b)(4) for the delta patient monitoring system.

Manufacturer Narrative

An initial log file analysis for the primus did not reveal any indication for the potential presence of a device malfunction.It can be derived from the logs that the ventilation was unremarkable in the beginning but that disturbances occurred during the wake-up phase after the dosage of volatile anesthetics was stopped.The device has posted appropriate alarms to indicate the measured deviations from the set ventilation parameter.The current understanding that there is no issue with the primus workstation which would require repair or correction is substantiated by the aspect that the unit was used for further procedures afterwards without recurrence of symptoms.A detailed analysis and assessment will be provided within a follow-up/final report.

Manufacturer Narrative

It was confirmed to dräger during the course of investigation that the patient died.The customer added the information that a breathing filter of type safestar 55 plus was used in the set-up, too.The primus anesthesia workstation was tested by dräger in follow-up of the event against full scope of specifications and, no deviations could be found.The log file covering the period in question could be analyzed which did not reveal any indication for the potential presence of a device malfunction.It can be derived from the logs that the ventilation was unremarkable in the beginning but that disturbances occurred during the wake-up phase after the dosage of volatile anesthetics was stopped.The device has posted appropriate alarms to indicate the measured deviations from the set ventilation parameter.The log further indicates that the device was used for other surgeries afterwards which substantiates the conclusion that there was/is no issue with the device which would require repair or correction.The delta patient monitor was tested by a third-party service provider whereby no deviations from specification were determined.There was no log information in regard to monitored parameter and potential alarms issued by the monitor available anymore since the patient was released from monitoring which erases all data.The error log does not contain any entry for the relevant period which leads to the conclusion that the device worked as intended during the concerned procedure.The breathing filter was not handed over to dräger for evaluation so far.Dräger concludes the following: the exact root cause for the disturbance of ventilation cannot be determined on the base of the available information.The log file for the primus indicates that the device has delivered as set and that the procedure was uneventful until the wake-up phase started.The dosage of volatile anesthetics was active between start of procedure at 09:25 am until approx.10:00 am.In the following, ventilation was disturbed which triggered numerous alarms at the workstation.The patient was disconnected from the device after 1pm.Dräger concludes that there was room to react upon the alarms posted by the device.There was no event data for the patient monitor available but from the fact that no nonconformities were found during testing in follow-up is concluded that the device worked as intended during the course of event.No statement in regard to the breathing filter can be made since it was not made available to dräger.

Event Description

On (b)(6) 2023 it was reported to a draeger technician that an event occurred with a draeger infinity delta patient monitor mounted to a draeger primus anesthesia workstation where it was reported that the monitor did not alarm and the involved patient died.The customer is not providing further information until their internal investigation is completed.On 5jun2023 dräger received a user facility report regarding the event in which ventilation problems during a surgery performed with a combination of a dräger primus anesthesia workstation and a dräger delta patient monitoring system were mentioned.As further information is not currently available, we are considering the allegation to be against both the primus and the delta.Remark: since the product responsibility for the used devices is with two different manufacturing sites in the dräger organization, two files for the documentation of investigation have been opened: internal reference # (b)(4) for the primus anesthesia workstation and # (b)(4) for the delta patient monitoring system.

• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17096419
• MDR Text Key: 316839909
• Report Number: 9611500-2023-00213
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2008
• 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