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

Model Number FLOW-I C20

Device Problems Contamination /Decontamination Problem (2895); Output Problem (3005)

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

Event Date 04/25/2021

Event Type  malfunction  

Event Description

It was reported that the sevoflurane 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).

Manufacturer Narrative

The vaporizers with yellow residue has been shown to contain hydrogen fluoride by chemical analysis during the ongoing investigation.The anesthetic agent sevoflurane is susceptible to various types of chemical degradation.This report is a result of the confirmation of the presence of hydrogen fluoride and has prompted a review of complaints and the returned vaporizers for the past 2 years.

Event Description

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

Manufacturer Narrative

The investigation has been completed.The vaporizer was returned for investigation and the reported issue was confirmed.The yellow residue inside the vaporizer has been analyzed in a chemical analyze and the cause of the yellow residue is due to degradation of sevoflurane creating hydrogen fluoride.The concerned vaporizers are sevoflurane with maquet fill and safe-t-seal (which is keyed to sevoflurane from baxter).A root cause analysis has been performed regarding the formation of hydrogen fluoride within sevoflurane vaporizers.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-I
• 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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 12836352
• MDR Text Key: 280962484
• Report Number: 8010042-2021-02731
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0468-2022
• Patient Sequence Number: 1