MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM SMART OCCLUDER - RH; CARDIOPULMONARY BYPASS SYSTEM AIR BUBBLE/FLUID LEVEL DETECTOR

Model Number	QSOR
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation ongoing, event determined to be reportable due to interruption of blood flow.No harm to the patient due to this incident.Follow up report to be provided upon completion of investigation.
Event or Problem Description
During a cardiopulmonary bypass (cpb), an issue occurred with the venous occluder on console ph1004201.While attempting to fill the heart at the surgeon's request, the operator gradually closed the venous occluder.At the moment of trying to stabilize the level, the reservoir suddenly emptied completely, and the level sensor was triggered, preventing further manual control.It was then discovered that the venous occluder was fully closed, despite the screen indicating otherwise.Attempts to reopen it using the "clamp open 100%" and "clamp release" buttons were unsuccessful.The operator had to unplug and reconnect the occluder, after which it restarted and control of the cpb was regained.Additional information: - the carriage test had been successfully completed prior to the procedure.- the occluder's blue led was steady during the incident.- the patient was in the cooling phase, so no clinical consequences resulted.

• Brand Name: QUANTUM SMART OCCLUDER - RH
• Common Device Name: CARDIOPULMONARY BYPASS SYSTEM AIR BUBBLE/FLUID LEVEL DETECTOR
• 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: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershirw GL29S-L ; UK GL29SL
• MDR Report Key: 23581844
• Report Number: 3006073153-2025-00282
• Device Sequence Number: 9641256
• Product Code: DTQ
• UDI-Device Identifier: 05060434423443
• UDI-Public: 05060434423443
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190282
• 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): 11/18/2025

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: QSOR
• Device Catalogue Number: 51-000074-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown