MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM ROLLER PUMP - 6"

Model Number	QRP6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During pre-installation, the bobbins were found to be slipping.
Additional Manufacturer Narrative
Once problem was identified, bobbin housing was opened and wear and tear was identified on the internal locking components.Worn components were replaced and the device was confirmed to operate as expected.This event was originally reported in a summary report 3006073153-2025-00059, 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 creation and submission of this report.

• Brand Name: QUANTUM ROLLER PUMP - 6"
• 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: 24566544
• Report Number: 3006073153-2026-00065
• Device Sequence Number: 8384528
• Product Code: DTQ
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: QRP6
• Device Catalogue Number: 51-000013-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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