MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM SMART OCCLUDER (ACCESSORY TO QUANTUM WORKSTATION); TUBE CLAMP

Model Number	QSOL
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that during a case a user had slowly attempted to close the venous occluder.When the user began to turn the know the occluder immediately closed.The user reset and then tried again.The issue happened again.There was no patient harm as a result of this incident.Spectrum medical considers a sudden or unintentional decrease in blood flow a reportable incident.
Additional Manufacturer Narrative
Logs were reviewed which confirmed the incident.But do not indicate cause.Testing was unable to reproduce the incident.

• Brand Name: QUANTUM SMART OCCLUDER (ACCESSORY TO QUANTUM WORKSTATION)
• Common Device Name: TUBE CLAMP
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 21281736
• Report Number: 3006073153-2025-00030
• Device Sequence Number: 7830856
• Product Code: DTQ
• UDI-Device Identifier: 05060434423436
• UDI-Public: 05060434423436
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 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: 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: 05/17/2023
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown