MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM WORKSTATION (QUANTUM PUMP CONSOLE); HEART LUNG MACHINE

Model Number	QWS
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per account rep: this happened when they were using 6.6.1 software and they have since reverted back sw.Unit has been used successfully since reverting back to old software.
Event or Problem Description
While using pco2 auto-regulation this morning, pco2 was unable to maintain set point.Pco2 was set at 40 and the sweep started at 2lpm.Over 15 mins the sweep went to.5 lpm and the pco2 was reading 29.When the clinician tried again later in the case and it worked as expected.

• Brand Name: QUANTUM WORKSTATION (QUANTUM PUMP CONSOLE)
• Common Device Name: HEART LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: asia lukuc ; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 21272166
• Report Number: 3006073153-2025-00019
• Device Sequence Number: 8071528
• Product Code: DTQ
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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: 09/08/2022
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (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