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

Model Number	6887900
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sevoflurane vaporizer in the anesthesia workstation failed in the system checkout.The vaporizer is the unit containing anesthetic agent in the anesthesia workstation.When the vaporizer was received for investigation, it was found that the vaporizer had a yellow/brown residue on the inside.There was no patient involvement.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned sevoflurane vaporizer with part number 6682282 and serial number (b)(6), has been completed.The performed investigation and analysis of the observed discoloration/corrosion (yellow/brown residue) inside the vaporizer have revealed a chemical degradation of sevoflurane, resulting in formation of hydrogen fluoride within the vaporizer.The investigation of this reported event has concluded that the hydrogen fluoride has been formed within the vaporizer during the transport of the vaporizer from the customer to the manufacturer for investigation of the reported system checkout failure.A root cause investigation on affected vaporizers has concluded that the presence of hydrogen fluoride is due to sevoflurane in contact with anodized aluminum with cold sealing leading to degradation of the anesthetic agent.The vaporizers are assembled with several parts, of which some are manufactured from aluminum.The aluminum parts undergo a surface treatment step, anodization.Most of the aluminum parts in the affected vaporizers comprise of cold sealed aluminum.To prevent this from occurring, a change will be implemented on affected vaporizers.The change consists of a switch from cold sealing anodization to hot sealing anodization.New vaporizers will be produced with hot sealed anodized aluminum parts.The field safety corrective action has been initiated with the aim to remove all the concerned vaporizers from the field.The removing of the concerned vaporizers is expected to be completed on 06/13/2025.Corrected data: a correction of field # d1 brand name, # d4 version or model #, # d4 unique identifier (udi) # and h4 manufacturer date were required.D1 ¿ brand name - previous brand name: flow-e, corrected brand name: flow-e anesthesia system, d4 ¿ version or model # - previous version or model #: flow-e, corrected version or model #: 6887900, d4 ¿ unique identifier (udi) # - previous unique identifier (udi) #: missing, corrected unique identifier (udi) #:(b)(4), h4 ¿ manufacture date - previous manufacturing date: 07/05/2021, corrected manufacturing date: 06/08/2021.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-E 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: 18835472
• Report Number: 8010042-2024-00412
• Device Sequence Number: 15313310
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)210608
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 6887900
• Device Catalogue Number: 6887900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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-1877-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown