MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM; QUANTUM ROLLER PUMP - 4 INCH

Model Number	QRP4
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
User contacted spectrum to report a faulty vent pumpt.When connected to the frame, the pump tile displayed "défaillance matériel" (hardware failure).The user first tested with another cable, then took the cerebro pump and connected it in place of, which allowed them to continue the case.There was no patient harm or delay to surgery.
Additional Manufacturer Narrative
The device is being returned and an investigation is ongoing.
Additional Manufacturer Narrative
Pump present heavy trace of liquid ingress inside the pump and outside.Pcb, flexi cable and other component are damaged by liquid.Pump replaced with a new one.Ensure dripping items are not hang above pumps to reduce the change of liquid ingress.Root cause determined to be user error.
Event or Problem Description
User contacted spectrum to report a faulty vent pumpt.When connected to the frame, the pump tile displayed "défaillance matériel" (hardware failure).The user first tested with another cable, then took the cerebro pump and connected it in place of, which allowed them to continue the case.There was no patient harm or delay to surgery.

• Brand Name: QUANTUM
• Common Device Name: QUANTUM ROLLER PUMP - 4 INCH
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: raffaella tommasini ; commerce road; ashville business park; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 24246342
• Report Number: 3006073153-2026-00015
• Device Sequence Number: 9617881
• Product Code: DTQ
• UDI-Device Identifier: 05060434420794
• UDI-Public: 05060434420794
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/25/2026

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: QRP4
• Device Catalogue Number: 51-000011-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2026
• Supplement Date Received by Manufacturer: 01/24/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2018
• 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