MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM SMART OCCLUDER - LH; ELECTRONIC TUBE CLAMP

Model Number	QSOL
Medical Device Problem Codes	Restricted Flow rate (1248); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Spectrum medical staff was present to train the perfusionists in the 3rd week of installation.The system was set correctly and in initiation mode.Before starting with cpb, 50ml was given for 2-3 times and all was good.When the perfusionist started bypass and increased the flow, the vein qso was opened to produce a minimal flow, but the artery qso did not open (led flashing).They decided to exit from the initiation mode, and the vein occluder went to a fully open position, however the artery occluder remained closed.Flow was stopped, spectrum medical staff removed the tubes manually from the qso and the flow to the patient was restored.After that, the perfusionist wanted to reuse the arterial qso.Before reinserting the tube in the qso, they did the carriage test and the function was ok.After that, all the features were correct and they used the qso until the end of the operation with no further issues.
Additional Manufacturer Narrative
Device continued to be used after the incident, with no further issues.Device being returned to manufacturer, to be investigated on return.
Event or Problem Description
Spectrum medical staff was present to train the perfusionists in the 3rd week of installation.The system was set correctly and in initiation mode.Before starting with cpb, 50ml was given for 2-3 times and all was good.When the perfusionist started bypass and increased the flow, the vein qso was opened to produce a minimal flow, but the artery qso did not open (led flashing).They decided to exit from the initiation mode, and the vein occluder went to a fully open position, however the artery occluder remained closed.Flow was stopped, spectrum medical staff removed the tubes manually from the qso and the flow to the patient was restored.After that, the perfusionist wanted to reuse the arterial qso.Before reinserting the tube in the qso, they did the carriage test and the function was ok.After that, all the features were correct and they used the qso until the end of the operation with no further issues.
Additional Manufacturer Narrative
Device continued to be used after the incident, with no further issues.Device being returned to manufacturer, to be investigated on return.Follow up on 19-dec-2025: return of subject device to manufacturer, loaner provided to customer.Testing of subject device still ongoing.
Additional Manufacturer Narrative
Device contiued to be used after the incident, with no further issues.Device being returned to manufacturer, to be investigated on return.Follow up 19-dec-2025: return of subject device to manufacturer, loaner provided to customer.Testing of subject device still ongoing final 23-feb-2026: investigation at spectrum medical italy - could not reproduce error of the occluder not opening.No electrical or mechanical issues identified.Device sent to spectrum medical uk for further analysis investigation at spectrum medical uk - multiple test realised considering: several flow setpoints, endurance testing (open\closure multiple cycles), prolonged occlusion status.Additionally, complete analysis and inspection of the device has been performed.Occluder not opening error could not be reproduced after testing through full range of operation.Internal inspection completed, no issues identified.Root cause determined to be user misuse causing a rare mechanical anomaly, not reproducible under standard conditions.
Event or Problem Description
Spectrum medical staff was present to train the perfusionists in the 3rd week of installation.The system was set correctly and in initiation mode.Before starting with cpb, 50ml was given for 2-3 times and all was good.When the perfusionist started bypass and increased the flow, the vein qso was opened to produce a minimal flow, but the artery qso did not open (led flashing).They decided to exit from the initiation mode, and the vein occluder went to a fully open position, however the artery occluder remained closed.Flow was stopped, spectrum medical staff removed the tubes manually from the qso and the flow to the patient was restored.After that, the perfusionist wanted to reuse the arterial qso.Before reinserting the tube in the qso, they did the carriage test and the function was ok.After that, all the features were correct and they used the qso until the end of the operation with no further issues.

• Brand Name: QUANTUM SMART OCCLUDER - LH
• Common Device Name: ELECTRONIC TUBE CLAMP
• 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: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 23436263
• Report Number: 3006073153-2025-00278
• Device Sequence Number: 8533753
• Product Code: DTQ
• UDI-Device Identifier: 05060434424044
• UDI-Public: 05060434424044
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup,Followup
• Report Date (Section B): 02/23/2026

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: 51-000022-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2025
• Supplement Date Received by Manufacturer: 10/19/2025; 10/19/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/19/2025; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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