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

Model Number	QVM2
Medical Device Problem Codes	Calibration Problem (2890); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of log files shows issue stated, however this is not conclusive and device must be analysed on return.Device en route to manufacturer, to be investigated on return.
Event or Problem Description
Customer has noticed that feco2 is under-reading on the qvm2.They have recently replaced wag line filter, nomoline and full circuit and still seeing the same issue.Protection of the wag line in good- 2 fluid traps, 1 gas line protector changed out regularly, when condensation is seen, tubing system opened and left to dry out between cases.Underreading persists.
Event or Problem Description
Customer has noticed that feco2 is under-reading on the qvm2.They have recently replaced wag line filter, nomoline and full circuit and still seeing the same issue.Protection of the wag line in good- 2 fluid traps, 1 gas line protector changed out regularly, when condensation is seen, tubing system opened and left to dry out between cases.Underreading persists.
Additional Manufacturer Narrative
Review of log files shows issue stated, however this is not conclusive and device must be analysed on return.Device en route to manufacturer, to be investigated on return.Final report: 23-jan-2026: fluid ingress discovered following subject device investigation.There seems to be no issue seen with the feco2 - the unit will be recalibrated, due to the fluid ingress on the components they will need to be replaced.Root cause determined to be liquid ingress.Spectrum medical mandates that vacuum filters and water traps must be used and replaced routinely to prevent liquid ingress into the qvm.

• 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: 23776762
• Report Number: 3006073153-2025-00298
• Device Sequence Number: 9992781
• Product Code: DTX
• UDI-Device Identifier: 05060434422064
• UDI-Public: 05060434422064
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 01/23/2026

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
• Device Catalogue Number: 51-000081-00
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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