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

Model Number	QSOL
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event logs reviewed but could not confirm the reported fault.Event logs suggest the qso closed as expected when a bubble was triggered.490 2024-01-10t18:34:54.375z info bubble occl ch1, on (3), 491 2024-01-10t18:35:03.867z info bubble occl trig by ch1, val 3, 492 2024-01-10t18:35:03.867z info bubble occl ch1, disabled, 493 2024-01-10t18:35:03.867z info bubble occl ch2, disabled, 494 2024-01-10t18:35:03.867z info flow regulation: internal occlusion requested, 495 2024-01-10t18:35:03.877z info full occlusion: high profile: 34.3, 496 2024-01-10t18:35:06.474z info full occlusion completed.Review of device logs gave no indication of any faults with the qso.Unable to reproduce the reported fault when attempted in-house.Spectrum will work to improve logging in future software releases.
Event or Problem Description
Customer reported that while testing bubble detection, the arterial clamp didn't clamp when detecting a bubble.This happened 3 times in a row and worked fine afterwards.From the video, it seems that the arterial clamp is released but the qws show that it is in the open position.

• Brand Name: QUANTUM SMART OCCLUDER
• Common Device Name: TUBE CLAMP
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: asia lukuc ; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 21264511
• Report Number: 3006073153-2025-00016
• Device Sequence Number: 9538602
• Product Code: DTQ
• UDI-Device Identifier: 05060434423436
• UDI-Public: 05060434423436
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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: QSOL
• Device Catalogue Number: 51-000022-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (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