MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM ROLLER PUMP - 4 INCH

Model Number	QRP4
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned to spectrum medical for investigation.Investigation found that the blood contamination made finding what caused the initial stiffness in the bobbins impossible.The user stated they were aware of the faulty device and decided to use the device anyway, this is considered user error.Device is beyond economical repair due to fluid ingress (blood contamination).
Event or Problem Description
User reported that the bobbin of the roller pump was very stiff before bypass but continued to be used by team.User reported that they had difficulty setting the tubing in correct raceway due to stiff bobbin during the case the tubing "rucked up " and spilt causing an interruption to the blood flow.There was no patient harm as a result of this event.

• Brand Name: QUANTUM ROLLER PUMP - 4 INCH
• 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: 22802521
• Report Number: 3006073153-2025-00207
• Device Sequence Number: 20783061
• Product Code: DTQ
• UDI-Device Identifier: 05060434420794
• UDI-Public: 05060434420794
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/14/2025

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: 08/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown