MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM PUMP FRAME; PUMP CONSOLE FRAME

Model Number	QPF2
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation confirmed a faulty connection between the pump and frame due to wear of port overtime.Spectrum medical replaced the frame and power supply.
Event or Problem Description
During procedure, the quantum workstation screen froze and the perfusionist was unable to adjust the pumps.User performed hard reboot of the system after which the pumps stopped and had to be hand-cranked.There was no patient harm.Spectrum medical considers an event in which the pump stops to be reportable.
Additional Manufacturer Narrative
Investigation confirmed a faulty connection between the pump and frame due to wear of port overtime.Spectrum medical replaced the frame and power supply.
Event or Problem Description
During procedure, the quantum workstation screen froze and the perfusionist was unable to adjust the pumps.User performed hard reboot of the system after which the pumps stopped and had to be hand-cranked.There was no patient harm.Spectrum medical considers an event in which the pump stops to be reportable.

• Brand Name: QUANTUM PUMP FRAME
• Common Device Name: PUMP CONSOLE FRAME
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 21250070
• Report Number: 3006073153-2025-00010
• Device Sequence Number: 18411374
• Product Code: DTQ
• UDI-Device Identifier: 05060434420756
• UDI-Public: 05060434420756
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: QPF2
• Device Catalogue Number: 51-000025-00
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• Is the Device Labeled for Single Use? (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