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

Model Number	QSOR
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported pump flow interruption caused by the occluder when entering weaning mode, when the units were set to ml/min.This did not occur when the units were set to l/min.We consider interruptions to the blood flow to be reportable, despite no patient involvement in this instance.
Additional Manufacturer Narrative
Logs of the event were reviewed and confirmed that error was caused by a unit conversion error.Error causes the "initial weaning target" to be incorrectly calculated when the arterial flow probe is configured for ml/min, the occluder can be opened and pump started manually after that.This error is only an issue when entering weaning mode.There was no patient harm as a result of this issue.Error does not occur when arterial flow sensor is set to l/min.Device enhancement will be implemented to improve the workflow of entering weaning mode.

• Brand Name: QUANTUM SMART OCCLUDER
• Common Device Name: CONCOLE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 22585541
• Report Number: 3006073153-2025-00176
• Device Sequence Number: 4489102
• Product Code: DTQ
• UDI-Device Identifier: 05060434424044
• UDI-Public: 05060434424044
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: QSOR
• Device Catalogue Number: 51-000074-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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