MAUDE Adverse Event Report: Spectrum Medical LTD Quantum Roller Pump - 6 inch (QRP6)

Model Number	QRP6
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation revealed no external damage, nor visible damage of internals components , and no signs of liquid ingress inside the pump.Further investigation are ongoing in order to identify the root cause of the issue.
Event or Problem Description
The user reported pump issue during procedure: the pump did not spin and showed a pump speed error.A reset and loosening of occlusion was tried several times without success.The pump also went offline several times.No consequences occurred to the patient of for the procedure.
Event or Problem Description
The user reported pump issue during procedure: the pump did not spin and showed a pump speed error.A reset and loosening of occlusion was tried several times without success.The pump also went offline several times.No consequences occurred to the patient of the procedure.
Additional Manufacturer Narrative
Preliminary investigation revealed no external damage, not visible damage of internals components, and no signs of liquid ingress inside the pump.Further investigation are ongoing in order to identify the root cause of the issue.

• Brand Name: Quantum Roller Pump - 6 inch (QRP6)
• Common Device Name: Roller pump
• Manufacturer (Section D): Spectrum Medical LTD; ashville business park; commerce road; glouchester, glouchestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): Specttrum Medical LTD; ashville business park; commerce road; glouchester, glouchestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 25701374
• Report Number: 3006073153-2026-00163
• Device Sequence Number: 9747641
• Product Code: DTQ
• UDI-Device Identifier: 05060434420787
• UDI-Public: 05060434420787
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: QRP6
• Device Catalogue Number: 51-000013-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/03/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown