MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM VENTILATION MODULE; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number	QVM2-D-HM
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that the level sensor did not trigger an alert to indicate a lack of fluid.This type of event is considered reportable as there is the potential for serious patient harm to occur if the reservoir level were to be emptied without the user realizing.There was no patient harm in this instance.
Additional Manufacturer Narrative
Device has not yet been returned for investigation.Root cause determination is pending the results of an investigation.
Additional Manufacturer Narrative
Device has been returned.Root cause determination is pending the results of an investigation.
Event or Problem Description
User reported that the level sensor did not trigger an alert to indicate a lack of fluid.This type of event is considered reportable as there is the potential for serious patient harm to occur if the reservoir level were to be emptied without the user realizing.There was no patient harm in this instance.
Additional Manufacturer Narrative
Investigation was unable to replicate the reported issue.Testing of the sensor confirmed the unit triggers the level and bubble functionality correctly.The associated level sensor was also returned and confirmed to operate correctly.The reported problem could not be confirmed.
Event or Problem Description
User reported that the level sensor did not trigger an alert to indicate a lack of fluid.This type of event is considered reportable as there is the potential for serious patient harm to occur if the reservoir level were to be emptied without the user realizing.There was no patient harm in this instance.

• Brand Name: QUANTUM VENTILATION MODULE
• Common Device Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: cameron schmitt ; 481 munn road; suite 180; fort mill, SC 29715
• MDR Report Key: 23789006
• Report Number: 3006073153-2025-00303
• Device Sequence Number: 12142985
• Product Code: DTX
• UDI-Device Identifier: 05060434422071
• UDI-Public: 05060434422071
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K202733
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2026

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: QVM2-D-HM
• Device Catalogue Number: 51-000082-00
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 11/12/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/09/2026; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown