MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM ROLLER PUMP - 8"

Model Number	QRP8
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Determination of root cause is pending completion of investigation.
Event or Problem Description
User reported that the pump would not stop at the end of the bypass case.There was no patient harm; however, the user was not able to control the pump speed at this time, which is considered a reportable event.
Additional Manufacturer Narrative
Investigation was unable to reproduce problem.It was determined that the device was operating as expected.The pump did not stop since the interlocked cpg pump was not set to 0 rpm, and the arterial pump is intended to adjust to the cpg flow.Unrelated to reported event, investigation did identify minor damage and replaced damaged components.
Event or Problem Description
User reported that the pump would not stop at the end of the bypass case.There was no patient harm; however, the user was not able to control the pump speed at this time, which is considered a reportable event.

• Brand Name: QUANTUM ROLLER PUMP - 8"
• Common Device Name: ROLLER PUMP
• 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: 24019966
• Report Number: 3006073153-2026-00003
• Device Sequence Number: 10545658
• Product Code: DTQ
• UDI-Device Identifier: 05060434420770
• UDI-Public: 05060434420770
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: QRP8
• Device Catalogue Number: 51-000008-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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