MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM WORKSTATION 12.1" ELITE; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Model Number	QWS12E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/15/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation confirmed the adverse event occurred as the user described; however, there was no evidence of a problem with the quantum system that would have resulted in such event.It was concluded that the quantum system worked as intended and the adverse event occurred due to external factors from the quantum system.
Event or Problem Description
Adverse event occurred that resulted in patient death while patient was connected to the medical device.User reported that blood flow was unable to be re-established following cpr and patient experienced hemorrhage beneath the heart.The investigation determined that the device did not malfunction during use and was operating as intended.

• Brand Name: QUANTUM WORKSTATION 12.1" ELITE
• Common Device Name: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: cameron schmitt ; 481 munn road; suite 180; fort mill, SC 29715
• MDR Report Key: 22564806
• Report Number: 3006073153-2025-00174
• Device Sequence Number: 3825930
• Product Code: DRY
• UDI-Device Identifier: 05060434422309
• UDI-Public: 05060434422309
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202557
• 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): 07/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: QWS12E
• Device Catalogue Number: 51-000094-00
• 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: 06/23/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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: Death
• Patient Sex: Unknown