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

Model Number	QSOR
Medical Device Problem Codes	Mechanical Problem (1384); Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fault could not be replicated when the device came back for investigation.It was found however that the unit had been exposed to a blood spill.Found no damage caused by blood spill and deep-cleaned unit.Ran repeated full occlusion tests.As a precaution the unit was replaced.
Event or Problem Description
The perfusionist was in weaning mode but had to go back on bypass (he was not completely off yet and had some flow).He tried increasing the flow using the venous occluder but the flow did not go up.He got out of the weaning mode and selected the "open" icon in the venous tile but the occluder remained in the same position.He tried using the release button in the venous tile but the occluder bobbins still did not move.He physically took out the bobbins from the occluder to remove the venous line to go back on bypass.After the case, the perfusionist repositioned the bobbins back into the occluder.The bobbins were initially in the clamped position but the venous tile showed "released." he was able to move the bobbins to released position, then to clamped and to open without issue.This unit was replaced by on site bonded inventory.

• 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: 21281184
• Report Number: 3006073153-2025-00028
• Device Sequence Number: 7782116
• Product Code: DTQ
• UDI-Device Identifier: 05060434423443
• UDI-Public: 05060434423443
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 01/31/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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