MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAFESTAR 55 PLUS; FILTER, BACTERIAL, BREATHING-CIRCUIT

Device Problems Improper Flow or Infusion (2954); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/30/2023

Event Type  Death  

Manufacturer Narrative

The investigation has just started.The filter has not been handed-over to dräger so far; an initial log file analysis for the primus did not reveal any indication for the potential presence of a device malfunction.H3 other text : on-going.

Event Description

Dräger received a user facility report in which ventilation problems were reported, the concerned devices were a primus anesthesia workstation and a delta patient monitoring system which - according to the report - did not alarm.For administrative reasons, two cases were opened internally and reported to the authorities - dräger ref.(b)(4) for the primus and (b)(4) for the delta.Dräger has now received a second user facility report for the identical event, a disposable filter was named as the concerned product because it was used in combination with the other devices and is - according to the ufr - the supposed causing component.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 (bfarm (b)(4), mdr report no.9611500-2023-00213) and # (b)(4) (bfarm (b)(4), mdr report no.(b)(4) for the delta patient monitoring system.This third reference (b)(4) was assigned to the filter (bfarm (b)(4), mdr report no.9611500-2023-00229).

Event Description

Dräger received a user facility report in which ventilation problems were reported, the concerned devices were a primus anesthesia workstation and a delta patient monitoring system which - according to the report - did not alarm.For administrative reasons, two cases were opened internally and reported to the authorities - dräger ref.(b)(4) for the primus and (b)(4) for the delta.Dräger has now received a second user facility report for the identical event, a disposable filter was named as the concerned product because it was used in combination with the other devices and is - according to the ufr - the supposed causing component.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 (bfarm 16088/23, mdr report no.9611500-2023-00213) and # (b)(4) (bfarm 16088a/23, mdr report no.1220063-2023-00018) for the delta patient monitoring system.This third reference (b)(4) was assigned to the filter (bfarm 16088b/23, mdr report no.9611500-2023-00229).

Manufacturer Narrative

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.H3 other text : device not available for evaluation.

• Brand Name: SAFESTAR 55 PLUS
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• 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: 17189534
• MDR Text Key: 317721451
• Report Number: 9611500-2023-00229
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• 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: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death