MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20; GAS-MACHINE, ANESTHESIA

Model Number C20

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2017

Event Type  malfunction  

Event Description

It was reported that during patient treatment, while lowering the co2 absorber, the two co2 absorber valves were stuck in open position.There was no patient harm reported.(b)(4).

Manufacturer Narrative

The anesthesia workstation was investigated on site by the biomedical engineer.The absorber bypass valves in the patient cassette were found stuck in an open position.Unscrewing one of the absorber bypass valves solved the issue.The system was returned to clinical use after successful functional testing.The two absorber bypass valves are located in the patient cassette where the co2 absorber is docked, one at the inlet and one at the outlet.The main task of these valves are to lead the re-breathed patient gas through the co2 absorber in order to remove the co2 from the gas.Investigations and simulated use testing of similar cases found that it was possible to provoke stuck absorber valves by trapping n2o-rich gas more than 30 minutes in the compartment above the bypass valves.A sub-atmospheric pressure is then created inside the compartment when the n2o-gas is diffused through the silicone seals of the bypass valves to the gas outside that have a lower n2o concentration.This leads to the absorber bypass valves getting stuck.When the valves are stuck, the gas will continue passing through the absorber when the absorber is bypassed.This leads to a leakage during the time the absorber is replaced.A stuck absorber valve while the absorber is docked in place will not affect functioning of the system.

Event Description

(b)(4).

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 6471550
• MDR Text Key: 72358401
• Report Number: 8010042-2017-00154
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Date Device Manufactured: 04/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1