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

Catalog Number 8607000

Device Problems Unexpected Therapeutic Results (1631); Failure to Deliver (2338); Human-Device Interface Problem (2949)

Patient Problems Death (1802); Hypoxia (1918)

Event Date 03/11/2020

Event Type  Death  

Manufacturer Narrative

The investigation was started; the results will be provided in a follow-up report.

Event Description

It was initially reported, that the customer complained because the device did not offer o2 to the patient, leading to hypoxia.Further information was received 2020-03-30: the customer reported that the hypoxia led to bradycardia and to crp.It was further reported that the patient died.

Event Description

Please refer to the initial report.

Manufacturer Narrative

It was further reported that the symptom (patient hypoxia causing the patient¿s death) was most likely caused by the anesthesiologist keeping the auxiliary fresh gas outlet switch in the incorrect position.Using this switch, the user can switch the fresh gas flow between separate patient breathing circuits without changing the fresh-gas hose connections.Switching the flow is accomplished by moving the lever, located on top of the auxiliary fresh gas outlet switch, to the desired flow position.The functionality of the common fresh gas outlet switch is described in the fabius ifu and the adjusted switch position is printed / visible on the lever.In case the lever of the switch is in the gas outlet position (=external), the cosy will not receive fresh gas including o2 and anesthetic agent.It is understood that in the particular case, the auxiliary fresh gas outlet switch was in the gas outlet position (external for mask ventilation) and the patient was not connected to the external system but to the compact breathing system (cosy) of the fabius.In case of such a use error, a lack of fresh will develop in the cosy, leading to decreasing concentrations of e.G.Oxygen and other anesthetic gases, as described in the ifu.The integrated inspiratory oxygen concentration monitor of the involved fabius device ensures that the decreasing o2 concentrations will be obvious and alarmed depending on the alarm limits adjusted by the user.Based on the logfile analysis, one entry was found being in context to the described symptom.A ¿m001 o2<10%¿ entry was logged.This entry is on the one hand either logged if the measured fio2 concentration dropped below 10 vol.% or, on the other hand, if the fio2 sensor cable or the o2 sensor capsule is disconnected.In case the entry is logged due to a dropped fio2 concentration, the fabius alarms before the concentration underruns 10%.The fabius alarms for insp o2 low !!! (high priority) depending on the adjusted alarm limit by the user (lowest alarm limit is 18 vol.%).After underrunning 10%, the device continues the insp o2 low !!! alarm and the permanent display of 9% o2 concentration indicates the very low, hypoxic, o2 concentration.If this m001 entry is logged due to a faulty fio2 sensor cable or o2 sensor capsule, the same insp o2 low !!! is given until the o2 measurement is disabled.In this case, the o2 sensor fail ! alarm is given and no o2 parameters are displayed.As per iec 60601-2-13 (anesthetic workstations and their modules-particular requirements), additional monitoring of the concentrations of co2 and anesthetic agent is required when the machine is in use.Consequently, also the decreasing concentrations of anesthetic agents as well as the increasing co2 concentration will be observed and alarmed by the required external monitoring.Finally, based on this investigation, dräger concludes that the reported symptom was not caused by a device failure.The user set the fresh-gas outlet switch improperly to the external outlet and subsequently did not react on the changing gas concentrations.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESTHESA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9902380
• MDR Text Key: 185658069
• Report Number: 9611500-2020-00104
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death