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

Model Number	QCD37
Medical Device Problem Code	Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that despite passing the pre-bypass checks, the pump became inoperable when going on bypass.User used the hand-crank to generate flow and replaced the hlm with a backup.
Additional Manufacturer Narrative
Event logs were reviewed, revealing that the system was in safe flow modulation at the time of the event.During safe flow modulation, the pump speed cannot be increased.Any attempts to adjust the pump during safe flow will only occur once the system exits safe flow.The logs indicated that the system entered safe flow modulation after being triggered by the safe flow level sensor, which could be due to a low reservoir level, poor contact between the sensor head and the reservoir, or a faulty level sensor.The logs did not indicate an issue with the sensor and on-site testing confirmed the level sensor head responded to fluid presence and absence appropriately.Therefore, no device issue was discovered.

• Brand Name: QUANTUM CENTRIFUGAL DRIVE HIGH PRESSURE
• 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: 24663048
• Report Number: 3006073153-2026-00098
• Device Sequence Number: 21138987
• Product Code: DWA
• UDI-Device Identifier: 05060434421838
• UDI-Public: 05060434421838
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 03/23/2026

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: QCD37
• Device Catalogue Number: 51-000062-00
• 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: 03/09/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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