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

Model Number	QRP8
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please find the attached spreadsheet listing the serial numbers, component codes, investigation codes, and conclusion codes of the devices summarised in this summary report.
Event or Problem Description
Users and service engineers reported finding loose bobbins on their roller pumps.This would mean the bobbins were not locking on the tubing.In all of these cases there was no patient harm.
Event or Problem Description
During pre-installation, a faulty bobbin locking assembly was identified.
Additional Manufacturer Narrative
The pawl, ratchet and spring assembly was replaced and the device was confirmed to operate as expected.This event was originally reported in a summary report 3006073153-2025-00060, which was submitted in relation to the affected devices from the voluntary recalled performed by spectrum medical ltd (recall number z-0224-2025).Fda has since requested that each event for the devices related to the voluntary recall be individually submitted, resulting in the submission of this follow-up report in which the number of events has been reduced to one (1).Single mdrs shall be submitted for the events per the vmsr guidance.

• 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: 21698897
• Report Number: 3016480796-2025-00060
• Device Sequence Number: 21152750
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K173834
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0224-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown