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

Model Number	QCD37
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported centrifugal drive fails to rotate and emits a noise while trying to engage.There was no patient involvement and thus no patient harm.
Additional Manufacturer Narrative
Spectrum medical considers this event to be reportable; however, the results of the investigation are still pending.
Additional Manufacturer Narrative
Investigation concluded excess glue residue present in device, causing the malfunction.The device was cleaned and the issue was resolved.
Event or Problem Description
User reported centrifugal drive fails to rotate and emits a noise while trying to engage.There was no patient involvement and thus no patient harm.

• 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: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 21797583
• Report Number: 3006073153-2025-00094
• Device Sequence Number: 7694088
• Product Code: DWA
• UDI-Device Identifier: 05060434421838
• UDI-Public: 05060434421838
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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