MAUDE Adverse Event Report: QUASAR MEDICAL (THAILAND) CO LTD MICROSTREAM ADVANCE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	MVAIH
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Connection Problem (2900); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device co2 filter line broke during patient use, became disconnected at the luer connection, and exhibited bio-contamination from patient use.Additionally, the device heat seal was either not completed or not adequate during manufacturing.The filter line was found disconnected at the luer end while still connected to the ventilator on the other end at the patient bedside during intraoperative use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional info; d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the connector was off of the tubing.The connector was reconnected to the tubing where it seemed loose functionally and the filter line was connected to a device where it was recognized.It was reported that the device co2 filter line broke during patient use, became disconnected at the luer connection, and exhibited bio-contamination from patient use.Additionally, the device heat seal was either not completed or not adequate during manufacturing.The filter line was found disconnected at the luer end while still connected to the ventilator on the other end at the patient bedside during intraoperative use.The reported issues were confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MICROSTREAM ADVANCE
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): QUASAR MEDICAL (THAILAND) CO LTD; 340-1 moo 6 bowin sub-district; chonburi,20 20230 ; TH 20230
• Manufacturer (Section G): QUASAR MEDICAL (THAILAND) CO LTD; 340-1 moo 6 bowin sub-district; chonburi,20 20230 ; TH 20230
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22417150
• Report Number: 2936999-2025-00368
• Device Sequence Number: 7053797
• Product Code: CCK
• UDI-Device Identifier: 20884521761916
• UDI-Public: 20884521761916
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K181467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: MVAIH
• Device Catalogue Number: MVAIH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1384-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown