MAUDE Adverse Event Report: SPECTRUM MEDICAL QUANTUM PUMP CONSOLE; HEART LUNG MACHINE

Model Number	QRP4
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to return to the manufacturer for investigation.This is in transit.A follow up report will be submitted with the conclusions from the investigation.
Event or Problem Description
During a case it was reported that there was a hardware fault message and a flashing red/yellow light on the pump.A back up was used to complete the case successfully.We consider blood flow interruptions to be reportable, despite no harm to the patient involved.
Additional Manufacturer Narrative
The device was tested upon receipt by the manufacturer.Comprehensive testing was performed; however, the fault was unable to be reproduced and no evidence was found to indicate a possible failure mode.
Event or Problem Description
During a case it was reported that there was a hardware fault message and a flashing red/yellow light on the pump.A back up was used to complete the case successfully.We consider blood flow interruptions to be reportable, despite no harm to the patient involved.

• Brand Name: QUANTUM PUMP CONSOLE
• Common Device Name: HEART LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: edward blogg ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 22282325
• Report Number: 3006073153-2025-00146
• Device Sequence Number: 18213302
• Product Code: DTQ
• UDI-Device Identifier: 05060434420794
• UDI-Public: 05060434420794
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173834
• 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,Followup
• Report Date (Section B): 07/16/2025

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: QRP4
• Device Catalogue Number: 51-000011-00
• Device Lot Number: AU4004834
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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