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

Model Number	QRP8
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The perfusionist reported he noticed the 8" roller head on the heart lung machine losing occlusion at the end of the case.The flow probe was reading ~1l different than the calculated flow.The perfusionist made sure all of the shunts were closed.After the case, he checked occlusions again and found one roller was off by 10 clicks and the other was off by 12 clicks.He replaced this roller with a backup roller.Manufacturer response for roller pump, quantum perfusion system (per site reporter).Company identified that at high rpm (>190), occlusion locking mechanism can shift after a hard stop (lid open and safeties).Company replicated this issue in other 8" roller pumps.Company noted the exact rpm varies by pump, but is consistently 180 rpm or higher.Company states it will assess system adjustments to mitigate this issue.

• Brand Name: QUANTUM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; 481 munn road, suite 180; fort mills SC 29715
• MDR Report Key: 23424356
• Report Number: 23424356
• Device Sequence Number: 18187535
• Product Code: DTQ
• UDI-Device Identifier: 05060434420770
• UDI-Public: (01)05060434420770
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/01/2025
• Report Date (Section F): 10/02/2025

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: Other
• Device Model Number: QRP8
• Device Catalogue Number: 51-000008-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/02/2025