MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM ROLLER PUMP 4"

Model Number	QRP4
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion of investigation awaiting completion of investigation.
Event or Problem Description
User reported that a roller pump abruptly stopped during a case and the user was unable to restart.User reported a "strange noise" before it stopped.Pump stop is considered reportable.Patient was not harmed.

• Brand Name: QUANTUM ROLLER PUMP 4"
• Common Device Name: ROLLER PUMP
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 21157968
• Report Number: 3006073153-2025-00002
• Device Sequence Number: 18041172
• Product Code: DTQ
• UDI-Device Identifier: 05060434420794
• UDI-Public: 05060434420794
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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