MAUDE Adverse Event Report: SPECTRUM MEDICAL 510QUANTUM FLOW SENSOR; BLOOD GAS MONITOR

Model Number	QFS5-ST-075
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the logs found that there was an error code 9, indicating that the sensor could not return a reading.Testing of the actual device found that the sensor could not detect, when on a cold circuit only (10 degrees celsius).
Event or Problem Description
User reported that the device failed to detect air in the venous line, until it was removed and replaced.We consider failure to detect/stop gross emboli to be reportable, despite no harm to the patient involved.

• Brand Name: 510QUANTUM FLOW SENSOR
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 23347808
• Report Number: 3006073153-2025-00263
• Device Sequence Number: 18506943
• Product Code: DRY
• UDI-Device Identifier: 05060434422019
• UDI-Public: 05060434422019
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Report Date (Section B): 10/21/2025

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: QFS5-ST-075
• Device Catalogue Number: 51-000079-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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