MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM HEATER COOLER MAIN UNIT; 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	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause determination is pending investigation.
Event or Problem Description
User reported that the heater-cooler was unable to cool during the procedure.There was no patient harm; however, spectrum medical considers this type of event to be reportable.
Additional Manufacturer Narrative
Root cause determination is pending investigation.
Event or Problem Description
User reported that the heater-cooler was unable to cool during the procedure.There was no patient harm; however, spectrum medical considers this type of event to be reportable.
Event or Problem Description
User reported that the heater-cooler was unable to cool during the procedure.There was no patient harm; however, spectrum medical considers this type of event to be reportable.
Additional Manufacturer Narrative
Investigation determined fault was rooted to a build-up of internal pressure.Unit will not begin cooling until internal pressure meets a required setpoint.Solenoid determined to have overheated, preventing the release of internal pressure.Part replaced and unit operated as expected.

• Brand Name: QUANTUM HEATER COOLER MAIN UNIT
• 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: 23838488
• Report Number: 3006073153-2025-00310
• Device Sequence Number: 21225565
• Product Code: DWC
• UDI-Device Identifier: 05060434420961
• UDI-Public: 05060434420961
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2026

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: QHC1
• Device Catalogue Number: 51-000058-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 11/18/2025
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/16/2026; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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