MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM CENTRIFUGAL DRIVE - CP37; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	QCD37
Medical Device Problem Code	Decreased Pump Speed (1500)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of device logs identified multiple events in which the maximum outlet pressure was triggered, which stops the pump.Before the final event, the user disabled bubble detection to prevent it from triggering.Investigation of the returned device confirmed that the device had no issues reaching the expected maximum speed.A similar event was able to be replicated by introducing air into the line which slowed the flow rate as the pump worked the air out of the system after which the pump increased to a normal flow.The device therefore worked as intended, but it is suspected that some obstruction (e.G.Air) caused the circuit to be over-pressurized, but was cleared when hand-cranking.
Event or Problem Description
User reported that the pump would not achieve normal flow, resulting in the user hand-cranking for the case until normal flow was achieved.There was no harm to the patient.

• Brand Name: QUANTUM CENTRIFUGAL DRIVE - CP37
• Common Device Name: CONTROL, PUMP SPEED, 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: 22964070
• Report Number: 3006073153-2025-00227
• Device Sequence Number: 18394080
• Product Code: DWA
• UDI-Device Identifier: 05060434421838
• UDI-Public: 05060434421838
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K192838
• 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): 09/04/2025

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: QCD37
• Device Catalogue Number: 51-000062-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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