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

Model Number FLOW-C

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

It was reported that the sevoflurane vaporizer in the anesthesia workstation failed during system checkout and generated a technical error code.When the vaporizer was received for investigation it was found that the vaporizer had a yellow residue on the inside.The vaporizer is the unit containing anesthetic agent in the anesthesia workstation.There was no patient harm.Manufacturer's reference #: (b)(4).

Event Description

Manufacturer's reference #: (b)(4).

Manufacturer Narrative

The investigation has been completed.The yellow residue inside the vaporizer has been subjected to a chemical analyze and the cause of the yellow residue is due to degradation of sevoflurane creating hydrogen fluoride.A root cause analysis has been performed regarding the formation of hydrogen fluoride within sevoflurane vaporizers.This issue has only been observed when using sevoflurane piramal and baxter sevoflurane.The root cause analysis found that changes in design and manufacturing process introduced in 2018 was the reason 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 happening the sevoflurane vaporizer will be redesigned.The fsca has been initiated to remove all the concerned vaporizers from the field.The removing of the concerned vaporizers are to be completed until (b)(6) 2023.

• Brand Name: FLOW-C
• Type of Device: 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: 15075277
• MDR Text Key: 302835802
• Report Number: 8010042-2022-01269
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

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 Model Number: FLOW-C
• Device Catalogue Number: 6887700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0468-2022
• Patient Sequence Number: 1