MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM ROLLER PUMP

Model Number	QRP4
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion awaiting return of device and completion of investigation.
Event or Problem Description
During preventative maintenance, it was found that the quantum roller pump had an internal cable issue, causing it to stop during use.There was no patient involvement in this event.
Additional Manufacturer Narrative
Conclusion awaiting return of device and completion of investigation.Follow up: the investigation is ongoing, the device is still in the process of being returned.A follow up report will be submitted with the findings.
Event or Problem Description
During preventative maintenance, it was found that the quantum roller pump had an internal cable issue, causing it to stop during use.There was no patient involvement in this event.

• Brand Name: QUANTUM ROLLER PUMP
• Common Device Name: ROLLER PUMP
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 21344244
• Report Number: 3006073153-2025-00048
• Device Sequence Number: 12683953
• Product Code: DTQ
• UDI-Device Identifier: 05060434420794
• UDI-Public: 5060434420794
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 01/13/2025
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2020
• 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