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	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Spectrum medical conducted an investigation of the reported fault and confirmed the level sensor did not operate as intended.There was no visible damage to the level sensor or the port.
Event or Problem Description
The level sensor was triggering inappropriately when there was sufficient volume in the reservoir.Spectrum medical considers this to be a reportable event despite there being no patient involvement.

• 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: 22726692
• Report Number: 3006073153-2025-00189
• Device Sequence Number: 15541772
• Product Code: DTX
• UDI-Device Identifier: 05060434422071
• UDI-Public: 05060434422071
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 08/06/2025

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: QVM2-D-HM
• Device Catalogue Number: 51-000082-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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