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

Model Number	QWS
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the set volume of cardioplegia is delivered, the software stops the pump; however, there is some small delay between the software trigger and actual hardware response.The volumes displayed have some known error and review of event history logs demonstrated an actual discrepancy of less than 1%.Therefore, there was no device fault found.
Event or Problem Description
The user reported that the cardioplegia volume set, delivered, and recorded differed.There was no patient involvement or harm.

• Brand Name: QUANTUM WORKSTATION
• 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: 22533033
• Report Number: 3006073153-2025-00163
• Device Sequence Number: 18097570
• Product Code: DRY
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 07/17/2025

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
• 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: 06/17/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2021
• 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