MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM SMART OCCLUDER - RH

Model Number	QSOR
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial investigation awaiting return of device to spectrum medical.
Event or Problem Description
User reported that during the case the pump and occluder were working without issue.The user set the demand for the pump down to zero and the occluder clamps closed as expected.At the end of the case (while in weaning mode) the user tried to continue transfusing but the pump did not turn and the occluder camps remained closed.This was not expected.The user exited weaning mode and proceeded to transfuse manually.There was no patient harm as a result of this issue.
Additional Manufacturer Narrative
Initial investigation awaiting return of device to spectrum medical.Device returned to spectrum medical, awaiting further investigation.
Event or Problem Description
User reported that during the case the pump and occluder were working without issue.The user set the demand for the pump down to zero and the occluder clamps closed as expected.At the end of the case (while in weaning mode) the user tried to continue transfusing but the pump did not turn and the occluder camps remained closed.This was not expected.The user exited weaning mode and and proceeded to transfuse manually.There was no patient harm as a result of this issue.

• Brand Name: QUANTUM SMART OCCLUDER - RH
• Common Device Name: OCCLUDER
• 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 GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 22675222
• Report Number: 3006073153-2025-00187
• Device Sequence Number: 5659429
• Product Code: DTQ
• UDI-Device Identifier: 05060434423443
• UDI-Public: 05060434423443
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 07/31/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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