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

Device Problems Improper or Incorrect Procedure or Method (2017); Electrical Shorting (2926)

Patient Problems Hypoxia (1918); Brain Injury (2219)

Event Date 11/27/2018

Event Type  Death  

Manufacturer Narrative

The investigation is still ongoing.The anesthesia machine has been quarantined.An appointment for checking the device and securing the electronic logbooks is still to be agreed.

Event Description

It was reported that a patient had not been properly connected to the anesthesia machine with the hose system.The y-piece would have been short-circuited with a hose element, so that the patient could not be supplied with fresh gas.This error apparently went unnoticed for 7 minutes.According to the customer, the patient has suffered an "apallic syndrome".

Event Description

Please refer to the initial-report.

Manufacturer Narrative

During an onsite-meeting the electronic logbook of primus was secured.The breathing circuit used during the incident was no longer available.Since the users had continued to use the primus for about a week after the incident, the relevant logbook records have already been overwritten by newer ones, so that a reconstruction of the events was no longer possible.The investigation was therefore based on the available information only.The affected breathing circuit is a disposable one where the tubing is not bonded to the y-piece.The instructions for use of the breathing circuits describe the set-up of hoses, water trap and y-piece schematically.The instructions for use of the primus describe the individual steps for the correct connection of the patient to the anaesthetic machine.For this particular case a use error was found to be the root cause.Despite the instructions, the hoses were connected in such a way that the two ports of the y-piece were short-circuited.In addition, the primus's inspiratory and expiratory ports were apparently shorted with the remaining tubing.Such a ¿misconnection¿ is easily recognizable before use, because the hoses do not form a coherent system but rather two subsystems that are decoupled from each other.However, if the fault is not noticed before use, the patient cannot be ventilated.The primus has an integrated gas measurement, which measures the o2, co2 and anesthetic gas concentration at the y-piece.In case of a short-circuited breathing circuit, the o2 value drops while the co2 value increases.This leads to audible and visible alarms (insp.O2 low, insp.Co2 high).Since no respiratory phase can be derived from the co2 readings in such a case, the unit generates an apnoe co2 alarm.Depending on the resistance and compliance of the hose element, which forms he short-circuit of the inspiratory and expiratory ports, further volume and pressure related alarms are generated.In the present case, a series of user errors led to the patient damage, as the users had only noticed after several minutes that the patient was not ventilated.The investigation has not revealed a product or device error in connection with this particular case.However, as part of our global post market surveillance activities, a case was reported to us in (b)(4) 2018, in which a faulty connection of the breathing circuit resulted in the patient not being connected to the anesthesia machine.This resulted in a temporary, reversible deterioration of the patient¿s state of health.In this second case, the users reported that they believe that the breathing circuit was already pre-assembled in the packaging.In addition to the above mentioned cases, a third case was evaluated for the purpose of risk assessment.No patient was involved in this one, but the users reported that they had found about 5-7 of breathing circuits already improperly pre-assembled in the packaging.These were then correctly connected and subsequently used, so that we could not confirm the symptoms.However, we inspected our material on stock and found 2 out of 22,000 breathing circuits that had actually been pre-assembled improperly.At the end of 2018, dräger issued a field safety notice to inform the users about the need for careful pre-use testing.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8183825
• MDR Text Key: 130974307
• Report Number: 9611500-2018-00412
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death