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

Model Number	QCD22
Medical Device Problem Code	Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
User reported stopped pump which resulted in hand-cranking.Spectrum medical considers this type of event to be reportable; however, there was no patient harm.
Additional Manufacturer Narrative
Device logs show that zero flow was triggered due to bubble detection.System was alerting for low flows and high pressures, triggering zero flow.This is the expected functioning of the system.There was no issue with the device.

• Brand Name: QUANTUM CENTRIFUGAL DRIVE
• Common Device Name: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• 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: 24626501
• Report Number: 3006073153-2026-00085
• Device Sequence Number: 8688744
• Product Code: DWA
• UDI-Device Identifier: 05060434421821
• UDI-Public: 05060434421821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/18/2026

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: QCD22
• Device Catalogue Number: 51-000061-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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