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

Catalog Number 8604700

Device Problems Contamination (1120); Incorrect Measurement (1383); Increased Sensitivity (2535)

Patient Problem Tachycardia (2095)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

The investigation has been started; results will be provided within the follow-up report.

Event Description

It was reported during a case the o2 and tidal volume readings on the fabius device did not match the readings of the phillips monitor.Customer states that this had an impact when dosing medication for the during the procedure.It was conveyed to the technician that two separate anesthesiologists dosed the patient medication which led to an overdose.Based on the available information, it could be stated that a device malfunction causing the reported wrong medication given seems very unlikely.It was explained that the first anesthesiologist dosed fentanyl because the patient heart rate was elevated.Then the anesthesiologist went to lunch and the 2nd anesthesiologist dosed the patient again.They flatlined the patient and then provided narcan to reverse the overdose.As further reported, the user did not allege incorrect sevo or des readings.Based on that, it could not be confirmed or comprehended why the user reported that the readings not matching between fabius and monitor led to the overdose.The fabius device is equipped with an integrated pressure-, flow- and inspiratory oxygen monitoring.Deviations from set/expected parameters are therefore obvious for the user and will be alarmed depending on the alarm limits adjusted by the user.As per iec 60601-2-13 and the instructions for use, additional monitoring of the concentrations of co2 and anesthetic agent is required when the machine is in use.Nevertheless, a use error leading to the incorrect levels of medication given to the patient could not be fully excluded.

Event Description

It was reported during a case the o2 and tidal volume readings on the fabius device did not match the readings of the ge patient monitor.Customer states that this had an impact when dosing medication for the during the procedure.It was conveyed to the technician that two separate anesthesiologists dosed the patient medication which led to an overdose.Based on the available information, it could be stated that a device malfunction causing the reported wrong medication given seems very unlikely.It was explained that the first anesthesiologist dosed fentanyl because the patient heart rate was elevated.Then the anesthesiologist went to lunch and the 2nd anesthesiologist dosed the patient again.They flatlined the patient and then provided narcan to reverse the overdose.As further reported, the user did not allege incorrect sevo or des readings.Based on that, it could not be confirmed or comprehended why the user reported that the readings not matching between fabius and monitor led to the overdose.The fabius device is equipped with an integrated pressure-, flow- and inspiratory oxygen monitoring.Deviations from set/expected parameters are therefore obvious for the user and will be alarmed depending on the alarm limits adjusted by the user.As per iec (b)(4) and the instructions for use, additional monitoring of the concentrations of co2 and anesthetic agent is required when the machine is in use.Nevertheless, a use error leading to the incorrect levels of medication given to the patient could not be fully excluded.

Manufacturer Narrative

The device was checked in follow-up of the event by a dräger service engineer and did not exhibit any deviation from specification.It could be clarified that the oxygen sensor has been calibrated by the user prior to the concerned procedure and it was verified during follow-up activities that calibration was still possible.Hence, it can be concluded that o2 measurement was functional during the concerned procedure as well.The root cause for the second observed aspect, the divergence between settings and readings for tidal volumes, can be attributed to the way the device was used; there was no technical malfunction: it could be determined that the heater function for the breathing system was not used and that significant condensation in the patient circuit has occurred.The condensation has soiled the expiratory flow sensor and affected the accuracy of readings.It can however be concluded that the device has delivered flow and pressure as set and that the divergence to the settings was a (virtual) problem of flow monitoring only.The device log file indicated further that the supervisor software function detected a negative pressure during piston movement and has temporarily stopped the ventilation.From the absence of other secondary error entries is concluded that the triggering condition was not related to the device itself - most probably, a bronchial suction system was used during ventilation.The device responded to this condition as intended.Dräger finally concludes the following: a likely explanation for the divergence in the tidal volumes was found and, this was related to the application and not to the device itself.No hint for the potential presence of a malfunction of the o2 measurement was found which leads to the conclusion that the difference between the readings of the fabius and the ge patient monitor were rather related to an inaccuracy of the patient monitor.The aspect that the patient accidentally received two doses of intravenous anesthetic cannot be attributed to the anesthesia workstation or to the way it was used.As already reported within the initial report, the first anesthesiologist dosed fentanyl because the patient heart rate was elevated.Most likely, a miscommunication between the first and second anesthesiologist led to the second dosage of fentanyl and in the following to the dosage of narcan.The user did not allege incorrect sevo or des readings.Based on that and the performed investigation, it could neither be confirmed nor comprehended why the user reported that the readings not matching between fabius and monitor led to the overdose.

• Brand Name: FABIUS GS
• 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: 15073652
• MDR Text Key: 296293879
• Report Number: 9611500-2022-00178
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2007
• 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