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	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been returned but root cause determination is pending the completion of an investigation.
Event or Problem Description
User reported bobbin failure during case, which is considered reportable per spectrum medical's criteria.There was no patient harm.
Additional Manufacturer Narrative
Device has been returned but root cause determination is pending the completion of an investigation.
Event or Problem Description
User reported bobbin failure during case, which is considered reportable per spectrum medical's criteria.There was no patient harm.
Event or Problem Description
User reported bobbin failure during case, which is considered reportable per spectrum medical's criteria.There was no patient harm.
Additional Manufacturer Narrative
Device was inventory disposed to prevent future clinical use.

• 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: 23730439
• Report Number: 3006073153-2025-00291
• Device Sequence Number: 21481252
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 11/05/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/02/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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