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

Model Number	6887700
Medical Device Problem Codes	Corroded (1131); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sevoflurane vaporizer in the anesthesia workstation failed in system checkout test.The vaporizer is the unit containing anesthetic agent in the anesthesia workstation.When the vaporizer was received for investigation, a yellow/brown residue was found inside the vaporizer.There was no patient involvement.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation has been completed.The returned sevoflurane vaporizer in this complaint, designed and keyed for use with sevoflurane from abbvie, has been investigated.The additional information received from the user states that the sevoflurane vaporizer has been used with sevoflurane from piramal.The performed investigations and analysis have revealed that the residue is a chemical degradation of sevoflurane resulting in formation of hydrogen fluoride.A root cause analysis has been performed regarding the formation of hydrogen fluoride within the sevoflurane vaporizers.This issue has only been observed when using sevoflurane from piramal and baxter.The root cause analysis found that changes in design and manufacturing process introduced in 2018, were the reasons for the formation of hydrogen fluoride.The main reason for the manufacturing change in 2018 was to facilitate easier assembling in production and to get a better sourcing of certain components.The surface treatment in the aluminum canister that form the main part of the liquid container in the vaporizer was found to be inadequate.To prevent this from occurring, the sevoflurane vaporizer has been redesigned.The fsca was initiated to remove all the concerned vaporizers from the field.The removing of the concerned vaporizers was completed (b)(6) 2024.The sevoflurane vaporizer model reported in this complaint can remain in use if it only has been used with sevoflurane from abbvie which is not the case in this complaint.

• Brand Name: FLOW-C ANESTHESIA SYSTEM
• Common Device Name: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 22402265
• Report Number: 8010042-2025-0001036
• Device Sequence Number: 8408064
• Product Code: BSZ
• UDI-Device Identifier: 07325710009765
• UDI-Public: (01)07325710009765(11)210909
• Combination Product (Y/N): N
• Initial Reporter Country: IZ
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2025

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
• Operator of Device: Health Professional
• Device Model Number: 6887700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0468-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown