MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QVM2-D-HM; 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	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Log review completed, confirming the issue.Subject device investigation, upon receipt.
Event or Problem Description
During case, pco2 @37 value trending very dangerously low, despite repeated capture/sync.Even immediately after performing a sync, pco2 value would drop back immediately to high-20s value.User checked wag line connections, set sweep to 10 lpm to blow off any condensation, and also emptied the sputum traps.Pipeline protectors were replaced.Factory reset of pco2 was not performed, nor was the nomoline replaced at the time.Pco2 continued alarming below their lower limit threshold throughout the case and required serial abgs to be performed for patient safety.All other parameters trended as normal.

• Brand Name: QVM2-D-HM
• 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: 25428946
• Report Number: 3006073153-2026-00146
• Device Sequence Number: 10373581
• 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: Not provided
• 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