MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM FLOW SENSOR

Model Number	QFS3-ST-200
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that upon starting delivery of cardioplegia, the arterial bubble was triggered, which caused the pump to stop as a safety measure.User assessed the circuit and did not find evidence of air, so the user cleared the alarm and resumed support to the patient.User reported that this occurred twice more during cardioplegia delivery.The user adjusted the settings for bubble intervention from "small" to "medium," which prevented further pump stops.
Additional Manufacturer Narrative
Investigation is pending the return of the device.

• Brand Name: QUANTUM FLOW SENSOR
• Common Device Name: FLOW SENSOR
• 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: 24952607
• Report Number: 3006073153-2026-00115
• Device Sequence Number: 21411545
• Product Code: DRY
• UDI-Device Identifier: 05060434421869
• UDI-Public: 05060434421869
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173591
• 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): 05/22/2026

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: QFS3-ST-200
• Device Catalogue Number: 51-000066-00
• Device Lot Number: FS3001146
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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
• Patient Sex: Unknown