MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM SMART OCCLUDER; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	QSOL
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Venous occluder engaged during a case with a patient when not activated.Perfusionist manually released the clamp.There was no patient harm.
Additional Manufacturer Narrative
System logs were reviewed.Logs did not show any unintentional occlusion/closing of the occluder.The device is in use by the customer with no further incidents.

• Brand Name: QUANTUM SMART OCCLUDER
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 20878470
• Report Number: 3006073153-2024-00140
• Device Sequence Number: 8928495
• Product Code: DTQ
• UDI-Device Identifier: 05060434421944
• UDI-Public: 05060434421944
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: 51-000022-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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