MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM FLOW SENSOR; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Model Number	QFS4-ST-120
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results of investigation are pending.Safe flow sensor was exchanged during case and issue was resolved.
Event or Problem Description
User reported inaccurate bubble alarms, which caused the occluder to clamp and flow to stop.There was no patient harm.
Additional Manufacturer Narrative
Results of investigation are pending.Safe flow sensor was exchanged during case and issue was resolved.Follow-up #1: spectrum medical is still awaiting device return for investigation.
Event or Problem Description
User reported inaccurate bubble alarms, which caused the occluder to clamp and flow to stop.There was no patient harm.
Additional Manufacturer Narrative
Results of investigation are pending.Safe flow sensor was exchanged during case and issue was resolved.Follow-up #1: spectrum medical is still awaiting device return for investigation.Follow-up #2: spectrum medical is still awaiting device return for investigation.
Event or Problem Description
User reported inaccurate bubble alarms, which caused the occluder to clamp and flow to stop.There was no patient harm.
Additional Manufacturer Narrative
Results of investigation are pending.Safe flow sensor was exchanged during case and issue was resolved.Follow-up #1: spectrum medical is still awaiting device return for investigation.Follow-up #2: spectrum medical is still awaiting device return for investigation.Follow-up #3: review of event logs reveals a loose connection between the flow sensor and the associated flow port., which can limit the signal emitted/received by the flow port.The user is advised to confirm that all sensors and cables are securely connected prior to use.The level sensor was checked on-site and confirmed to function as expected.
Event or Problem Description
User reported inaccurate bubble alarms, which caused the occluder to clamp and flow to stop.There was no patient harm.

• 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: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 21847391
• Report Number: 3006073153-2025-00105
• Device Sequence Number: 7954120
• Product Code: DRY
• UDI-Device Identifier: 05060434423269
• UDI-Public: 05060434423269
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup,Followup
• Report Date (Section B): 07/09/2025

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: QFS4-ST-120
• Device Catalogue Number: 51-000135-00
• Device Lot Number: FS4000360
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 03/13/2025; 03/13/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/15/2025; 06/13/2025; 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2021
• 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