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

Model Number	QRP8
Medical Device Problem Codes	Failure to Read Input Signal (1581); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation for this case is ongoing.A follow up report will be submitted with the findings.
Event or Problem Description
The user found an issue during bypass: while protected mode was active, the system detected a low reservoir (red level sensor led off, alarm displayed on screen), but the pump did not stop as expected.The user had to manually slow the pump.According to the user, this issue is intermittent, sometimes the pump stops as intended, and sometimes it does not.No harm occurred to the patient.
Additional Manufacturer Narrative
Visual inspection directly performed at customer's site and log analysis revealed that the arterial pump worked as expected, while it was found that the yellow level sensor was clearly damaged and the red one was functional, but slightly dirty.The customer used a tape that was procured independently, rather than one of the two types recommended in the ifu.
Event or Problem Description
The user found an issue during bypass: while protected mode was active, the system detected a low reservoir (red level sensor led off, alarm displayed on screen), but the pump did not stop as expected.The user had to manually slow the pump.According to the user, this issue is intermittent, sometimes the pump stops as intended, and sometimes it does not.No harm occurred to the patient.

• 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: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 23887117
• Report Number: 3006073153-2025-00320
• Device Sequence Number: 21245135
• Product Code: DTQ
• UDI-Device Identifier: 05060434420770
• UDI-Public: 05060434420770
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 02/25/2026

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: QRP8
• Device Catalogue Number: 51-000008-00
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown