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 05/23/2022

Event Type  malfunction  

Event Description

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

Event Description

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

Manufacturer Narrative

The investigation of the returned sevoflurane vaporizer concluded that the remaining liquid inside the vaporizer contained hydric fluoride, which was detected due to the steam of gas and smelling odour that came out from the vaporizer when it was drained.The inspection of parts after disassembly shows that some parts have been affected and corroded during the time inside the vaporizer.An additional observation was that the remaining liquid in the areas beyond the safety valve in the vaporizer did not show the steam and smell indicating the presence of hydric fluoride.As this vaporizer had been in use from 2014 until (b)(6) 2022, 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.

• 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: 15377737
• MDR Text Key: 304710667
• Report Number: 8010042-2022-01566
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/08/2022

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-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1