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

Model Number	QWS
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation found that the user did not disable a safety feature of the pump, which caused the pump to stop as they attempted to resolve a situation within the system.The device operated as intended, but due to knowledge error, the user was unable to interpret and resolve the error.While the device did not malfunction, if this use error were to recur, it could result in a risk of patient harm; therefore, spectrum medical has reported the event.
Event or Problem Description
User reported that the pump stopped during a case.There was no patient harm; however, spectrum medical considers this type of event to be reportable.

• 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: 21979697
• Report Number: 3006073153-2025-00116
• Device Sequence Number: 9061183
• Product Code: DRY
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/07/2025

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): Initial
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2018
• 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