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

Model Number C20

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2017

Event Type  malfunction  

Event Description

It was reported that after the autoclave of the co2 absorber bypass valve, the spring that is intended to help closing the valve had been stretched.This may lead to the valve not being able to close properly which in turn may result in a leakage when the co2 absorber is in bypassed position.There was no patient connected to the anesthesia workstation during the event.(b)(4).

Manufacturer Narrative

A received image of the reported co2 absorber bypass valve confirms the reported issue.The 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 is to lead the re-breathed patient gas through the co2 absorber in order to remove the co2 from the gas.The absorber bypass valves are equipped with spring-loaded cut-off valves that will automatically close the absorber bypass valves when the co2 absorber is bypassed and removed.With the absorber bypass valves closed, the bypass channel inside the cassette will be open.During the cleaning procedure of the patient cassette, these valves are removed from the patient cassette and put on a tool to be cleaned.To put the absorber bypass valves on the tool, the spring needs to be stretched.If the spring is stretched too much when inserting the tool, the spring may me deformed.This may lead to the valve not being able to close properly when the co2 absorber is in bypassed position.This fault will not affect the system function while the co2 absorber is docked in place.This fault can visually be noticed during assembling of the patient cassette after cleaning.Our conclusion is that the spring in the absorber bypass valve was stretched too much by the user during the cleaning procedure.

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: 7052555
• MDR Text Key: 93132406
• Report Number: 8010042-2017-00578
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• 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: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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