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

Model Number	QRP4
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation ongoing, to be provided in a follow up report.
Event or Problem Description
During preventative maintenance it noted that the module had an internal cable issue.There was no patient involvement.

• 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: 22893443
• Report Number: 3006073153-2025-00219
• Device Sequence Number: 8851907
• Product Code: DTQ
• UDI-Device Identifier: 05060434420794
• UDI-Public: 05060434420794
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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
• Report Date (Section B): 08/26/2025

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: AU4002427
• 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: 08/11/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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