MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM WORKSTATION 15"; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Model Number	QWS15S
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient harm, but spectrum medical is reporting the event pending the results of an investigation.
Event or Problem Description
User reported route and type of cardioplegia delivered during the case were being altered in the patient chart without prompting.There was no patient harm.
Additional Manufacturer Narrative
There was no patient harm, but spectrum medical is reporting the event pending the results of an investigation.Follow-up #1: investigation is still ongoing.
Event or Problem Description
User reported route and type of cardioplegia delivered during the case were being altered in the patient chart without prompting.There was no patient harm.
Additional Manufacturer Narrative
There was no patient harm, but spectrum medical is reporting the event pending the results of an investigation.Follow-up #1: investigation is still ongoing.Follow-up #2: investigation is still ongoing.
Event or Problem Description
User reported route and type of cardioplegia delivered during the case were being altered in the patient chart without prompting.There was no patient harm.
Additional Manufacturer Narrative
There was no patient harm, but spectrum medical is reporting the event pending the results of an investigation.Follow-up #1: investigation is still ongoing.Follow-up #2: investigation is still ongoing.Follow-up #3: investigation determined that teh device driver was not receiving the "off" message as a result of a parsing issue, which causing the cardioplegia application to log data in multiple columns.This is considered unexpected behavior of the system and will be considered as part of ongoing device improvement efforts.
Event or Problem Description
User reported route and type of cardioplegia delivered during the case were being altered in the patient chart without prompting.There was no patient harm.

• Brand Name: QUANTUM WORKSTATION 15"
• 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: 22026987
• Report Number: 3006073153-2025-00127
• Device Sequence Number: 21107057
• Product Code: DRY
• UDI-Device Identifier: 05060434422293
• UDI-Public: 05060434422293
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 08/08/2025

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: QWS15S
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 04/16/2025; 04/16/2025; 04/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/13/2025; 07/11/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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