MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM WORK STATION; EXTRACORPOREAL BLOOD GAS/PH MONITOR

Model Number	QWS15
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The qws was inspected after the case, but the specific software/touchscreen glitch could not be reproduced.Device to be investigated on return to hq.
Event or Problem Description
During reduction of cpb flow to 1.0 lpm for cross-clamp removal, the touchscreen failed to respond while deactivating the cross-clamp timer.Initiation mode was inadvertently activated.The arterial flow control dial display switched to "venous occluder," and arterial flow remained below 1.0 lpm with the clamp being open.Attempts to deactivate "initiation mode" were unsuccessful.The circuit was manually clamped, the surgical team was notified, and the cp37 pump head was placed on emergency hand-crank to restore flow and map.In a final attempt, initiation mode was deactivated successfully, the pump returned to external drive, and the patient was successfully weaned from cpb.The qws was inspected after the case, but the specific software/touchscreen glitch could not be reproduced.

• Brand Name: QUANTUM WORK STATION
• Common Device Name: EXTRACORPOREAL BLOOD GAS/PH 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; comemrce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 24468074
• Report Number: 3006073153-2026-00037
• Device Sequence Number: 9615758
• Product Code: DRY
• UDI-Device Identifier: 05060434422293
• UDI-Public: 05060434422293
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 02/27/2026

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
• Device Model Number: QWS15
• Device Catalogue Number: 51-000093-00
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown