MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM HEATER COOLER REGION 1; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number	QHC1
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Determination of root cause is pending an investigation of the device.
Event or Problem Description
User reported that the device failed to cool appropriately.There was no patient involvement; however, this type of event is considered reportable.
Additional Manufacturer Narrative
On-site investigation confirmed that the unit was able to heat and cool as expected; however, device logs revealed the unit has built up pressure due to the charging units being underfilled.The charging units were filled and pressure was manually relieved.The unit functioned as expected and passed preventative maintenance tests.
Event or Problem Description
User reported that the device failed to cool appropriately.There was no patient involvement; however, this type of event is considered reportable.

• Brand Name: QUANTUM HEATER COOLER REGION 1
• Common Device Name: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: cameron schmitt ; 481 munn road; suite 180; fort mill, SC 29715
• MDR Report Key: 22750250
• Report Number: 3006073153-2025-00201
• Device Sequence Number: 9672874
• Product Code: DWC
• UDI-Device Identifier: 05060434420961
• UDI-Public: 05060434420961
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 09/05/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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