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 02/22/2023

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

Manufacturer Narrative

The investigation of the returned sevoflurane vaporizer concluded that the remaining liquid inside the vaporizer contained hydro fluoric acid, which was detected due to the low ph value measured on the residue inside the vaporizer.The inspection of parts after disassembly shows that some parts have been affected and corroded during the time inside the vaporizer.One observation was that no residues was found in the areas beyond the safety valve in the vaporizer which indicates no presence of hydro fluoric acid in this area and that the chemical reaction inside the vaporizer have started after the vaporizer was taken out of use.Since this vaporizer had been in use from 2017 until (b)(6) 2023, the reaction that may have created the hydric fluoride is not considered to be due to design and normal use of the vaporizer.The true cause of the issue has not been determined.

Event Description

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

• 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: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 16945807
• MDR Text Key: 315377772
• Report Number: 8010042-2023-00956
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

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-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1