MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM WORKSTATION; MONITOR

Model Number	QWS 15"
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that whilst delivering cardioplegia in cardioplegia pressure regulation mode they were unable to regulate pressure.User reported that the pressure would overshoot the try to reduce to accommodate.To rectify this the user did not use regulation mode.There was no patient harm as a result of this issue.
Additional Manufacturer Narrative
Device has been returned to spectrum medical and is undergoing investigation.
Additional Manufacturer Narrative
The logs show pressure alarms.When the pump ran without pressure regulation, max pressure would still engage.Suggesting an obstruction in the line and could explain why pressure regulation would oscillate.Root cause - circuit setup.
Event or Problem Description
User reported that whilst delivering cardioplegia in cardioplegia pressure regulation mode they were unable to regulate pressure.User reported that the pressure would overshoot the try to reduce to accommodate.To rectify this the user did not use regulation mode.There was no patient harm as a result of this issue.

• Brand Name: QUANTUM WORKSTATION
• Common Device Name: MONITOR
• 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: 22195238
• Report Number: 3006073153-2025-00143
• Device Sequence Number: 9227509
• Product Code: DRY
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163657
• 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): 06/12/2025

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: QWS 15"
• Device Catalogue Number: 51-000001-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2020
• 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