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

Model Number	QVM2-D-HM
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Log file review investigation of subject device service history shows no prior issues.Upon receipt housing presents sings of liquid accumulation that has now dried.During internal inspection found nomoline exhaust tubing with traces of dried moisture accumulation.After nomo sub assembly and exhaust tubing device is working as expected.Root cause determined to be accidental damage.Fault caused by liquid ingress damage.Nomoline assembly replaced.Device passes calibration.No further action required.
Event or Problem Description
Nomoline icon flashing red after cpb initiation when they tried syncing the first blood gas at 10:37.Pipeline protector changed but continued alarming.Nomoline replaced with new disposable but alarming continued.User attempted to use outside suction on the nomoline port on the qvm2, to see if any condensation could be removed from the port itself.No resolution.Unplugged/replugged nomoline in multiple times and even replaced with a secondary nomoline.

• Brand Name: QUANTUM VENTILATION MODULE
• Common Device Name: CARDIOPULMONARY BYPASS SYSTEM GAS CONTROL UNIT
• Manufacturer (Section D): SPECTRUM MEDICAL LTD.; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD.; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 25428992
• Report Number: 3006073153-2026-00148
• Device Sequence Number: 10284884
• Product Code: DTX
• UDI-Device Identifier: 05060434422071
• UDI-Public: 05060434422071
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/08/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown