MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM; SMART OCCLUDER

Model Number	QSOR
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation ticket opened and ongoing.Conclusion of investigation will be provide in a follow up report.
Event or Problem Description
The customer reported a sudden locking of the venous occluder; and that opening the occluder was not possible.The customer had to open the occlude in a manual way.
Additional Manufacturer Narrative
The device was returned and an investigation found the following.A visual inspection showed the occluder has marks and wear with some paintwork worn down to bare metal.No issues were found with carriage movement.Multiple carriage test were done with no issue.Event logs still inside the device memory no longer contain the day the event occurred.Logs provided from the case show the issue but there is an opinion that a particularly soft tube was kinked during the case which caused the issue, and that there is no fault with the occluder.Connected occluder to a qws, and 6" pump with 3/8" x 3/32" water loop.Connected two flow sensors and level sensor.Set up flows and level for safe and also protected mode and tested bubble alerts and reservoir level alerts.All flow ports work.All pressure ports work.Level sensor port works.Safe and protected mode cause the occluder to clamp correctly, and it always releases when alert warnings are cleared.Cannot find a fault.No fault found with this device.
Event or Problem Description
The customer reported a sudden locking of the venous occluder; and that opening the occluder was not possible.The customer had to open the occlude in a manual way.

• Brand Name: QUANTUM
• Common Device Name: SMART OCCLUDER
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: raffaella tommasini ; commerce road; ashville business park; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 24320428
• Report Number: 3006073153-2026-00022
• Device Sequence Number: 10041631
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 04/08/2026

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: QSOR
• Device Catalogue Number: 51-000074-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2019
• 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