MAUDE Adverse Event Report: SPECTRUM MEDICAL QUANTUM HEATER-COOLER; CARDIOPULMONARY BYPASS SYSTEM HEATING/COOLING UNIT

Model Number	QHC1
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection conducted in house found no physical damage with the unit.Review of logs revealed a manifold pressure alarm which prevented the unit from reaching temperature setpoints, by releasing the pressure build-up via the mushroom valves and recharging the unit operated as expected.
Event or Problem Description
User reported that the device would not cool during a case.The device was swapped for a back up, to complete the case successfully.We consider inability to cool to be reportable, despite no harm to the patient involved.

• Brand Name: QUANTUM HEATER-COOLER
• Common Device Name: CARDIOPULMONARY BYPASS SYSTEM HEATING/COOLING UNIT
• Manufacturer (Section D): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 23378705
• Report Number: 3006073153-2025-00270
• Device Sequence Number: 21132773
• Product Code: DWC
• UDI-Device Identifier: 05060434420961
• UDI-Public: 05060434420961
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K212657
• 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): 10/24/2025

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: QHC1
• Device Catalogue Number: 51-000058-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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