MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM SMART OCCLUDER - LH; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	QSOL
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that the arterial occluder would not fully close and they had to use a clamp.There was no patient harm; therefore, the event is not considered reportable.
Additional Manufacturer Narrative
Root cause determination is pending completion of investigation.
Additional Manufacturer Narrative
Root cause determination is pending completion of investigation.
Event or Problem Description
User reported that the arterial occluder would not fully close and they had to use a clamp.There was no patient harm; therefore, the event is not considered reportable.
Additional Manufacturer Narrative
There was no damage to the device identified upon inspection.On a test circuit, the occluder performed as expected with both a roller pump and a centrifugal pump.The test was repeated to confirm consistent results from the occluder.The issue was not able to be replicated during the investigation.
Event or Problem Description
User reported that the arterial occluder would not fully close and they had to use a clamp.There was no patient harm; therefore, the event is not considered reportable.

• Brand Name: QUANTUM SMART OCCLUDER - LH
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, 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: 23723666
• Report Number: 3006073153-2025-00289
• Device Sequence Number: 10641550
• Product Code: DTQ
• UDI-Device Identifier: 05060434424044
• UDI-Public: 05060434424044
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190282
• 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): 01/30/2026

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: QSOL
• Device Catalogue Number: 51-000022-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 11/03/2025; 11/03/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/02/2026; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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