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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Misconnection (1399); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

This report is filed as requested from the mhra.For the investigation the provided information were analysed.The problem was found before use on a patient.When unplugging the oxygen pipeline of the central gas supply, the device alarms the missing o2 supply.No indication for a technical failure of the primus was found.The root cause was a communtation of the auxiliary gas outlet sockets with the cylinder gas inlets due to human error, probably during maintenance.To correctly identify the ports, their assignment to the different gas sources and accessories is printed on the back of the device above the gas inlet block.Furthermore, all ports of the gas supply block including the outlets are shown and labelled in the instructions for use (chapter overview, subchapter gas inlets).Additionally, the subchapter connecting the reserve gas cylinders for o2 and n2o contains a detailed description how to connect the backup cylinders.Also the auxiliary outlet can be separated from the inlets by its size as it is about 25mm longer.The device's design is in accordance to all relevant standards.The optional auxiliary o2 outlet was installed because the primus was ordered with external o2 flow tube.The external o2 flow tube was connected to the device in question.The primus instructions for use contain the following general advice: if accessories are connected to the optional o2 or air outlets on the gas inlet block, make sure they are working correctly.Consequently, the device check (prior to use) contains a dedicated test step, that advises the user to "adjust the flow knob and make sure the float moves freely over the full range of the flow tube." in case the connections are swapped as reported in this particular case, this test would fail and the incorrect connection would become obvious.The service engineers have already been re-trained, the user is aware of the device¿s behaviour.The devices on site were checked in regard to the correctness of the gas connections.The problem of the exchanged gas connectors was rated as a single event, as no similiar complaints were filed since more than nine years.

Event Description

It was reported that when carrying out pre-use checks on the draeger primus anaesthetic machine in day theatre 2 the odp found that when the oxygen pipeline was unplugged there was no backup oxygen supply from the oxygen cylinder on the rear of the machine.On checking the machine it was found that when draeger had installed the new monitoring they had incorrectly connected the oxygen cylinder hose to the aux flowmeter nist fitting instead.Further explanation from senior medical engineer: the issue was picked up on by a senior o.D.P.Who as part of her machine checks disconnected the oxygen pipeline and found that there was no backup oxygen supply.The machine did not fail its p.O.S.T.As the cylinder pressure sensor was plugged in and the machine was displaying cylinder contents and a green led on the front panel.We understand that the draeger engineers, after fitting the new monitoring had completed a p.O.S.T.Before returning the machine to theatres but this did not detect the problem.I have also carried out a p.O.S.T.With the hose disconnected from the n.I.S.T.Fitting on the gas block, the regulator hose blanked off and the cylinder turned on and it still passes a p.O.S.T.The issue appears to be that there are two oxygen n.I.S.T.Fittings next to each other, one in and one out, and whilst n.I.S.T.Stops different gas types from being interchanged it does not stop these two connections for being swapped over with potentially very serious consequences.It also shows that the p.O.S.T.Is only looking for cylinder pressure and not the presence of the oxygen supply to the machine.The concerns about the design of this device are that the "in" oxygen port and the "out" oxygen port are not sufficiently different and therefore and the oxygen cylinder line is able to be attached to the "out" port.Furthermore i am concerned that because the transducer measuring the oxygen pressure is attached to the cylinder it will report the presence of supplementary oxygen even if the line is attached to the wrong port and still satisfy the self-test.

• 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
• MDR Report Key: 16003504
• MDR Text Key: 308471600
• Report Number: 9611500-2022-00347
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2013
• 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