MAUDE Adverse Event Report: Spectrum Medical Ltd Quantum Flow Sensor; Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Model Number	QFS1-ST-075
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported that the sensors were incorrectly triggering bubble alarms when there was no air present in the line.There was no patient harm; however, spectrum medical considers this type of event to be reportable.
Additional Manufacturer Narrative
Pending investigation.

• Brand Name: Quantum Flow Sensor
• Common Device Name: Monitor, Blood-Gas, On-Line, 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: 25634961
• Report Number: 3006073153-2026-00158
• Device Sequence Number: 9736282
• Product Code: DRY
• UDI-Device Identifier: 05060434421975
• UDI-Public: 05060434421975
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/24/2026

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: QFS1-ST-075
• Device Catalogue Number: 51-000075-00
• Device Lot Number: FS1001032
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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