MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM FLOW SENSOR FS 9/16 X 0.75M (ID 3/8" X WALL 3/32")

Model Number	QFS4-ST-075
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been returned to spectrum medical, investigation is yet to be conducted.Details of investigation will be provided in a follow up to this report.
Event or Problem Description
Bubble alarm was triggered after the cross-clamp was removed during a clinical case.According to the perfusionist, there was no visible air in the circuit, and all other safety systems functioned as expected.
Additional Manufacturer Narrative
Upon receival, sensor present damage in housing.Housing damage could create interference on flow/bubble readings.During testing unable to replicate reported issue.Accidental damage, damage on sensor housing.Device replaced under sentinel.
Event or Problem Description
Bubble alarm was triggered after the cross-clamp was removed during a clinical case.According to the perfusionist, there was no visible air in the circuit, and all other safety systems functioned as expected.

• Brand Name: QUANTUM FLOW SENSOR FS 9/16 X 0.75M (ID 3/8" X WALL 3/32")
• Common Device Name: FLOW SENSOR
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 22530402
• Report Number: 3006073153-2025-00162
• Device Sequence Number: 15458097
• Product Code: DRY
• UDI-Device Identifier: 05060434422002
• UDI-Public: 05060434422002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: QFS4-ST-075
• Device Catalogue Number: 51-000078-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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