MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM WORKSTATION 12" ELITE; MONITOR/CONSOLE

Model Number	QWS12E
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Events occurred during the 1500 hour as follows: 1.Ecmo specialist noticed negative art flow in parallel with ecmo primer noticing backward flow 2.Patient clamped off immediately - hand cranking resumed 3.Clinicians started troublesthooting a.Reset qws - tried getting sweep gas to connect to tanks but was running short on tubing, so did not do a hard reset from the bottom of the frame b.Went into admin mode to ensure they had counterclockwise selected, swapped to clockwise, unclamped, no change.Went back to counterclockwise, no change.C.Swapped out roller pump unit while remaining on same frame/qws/qvm d.Regained forward counterclockwise flow 4.Red herring - this was immediately after a raceway walk and prior to starting, specialist turned down flow to "off", there was still a whiff going through so primer tapped the stop button (prior to lifting lid), screen notification popped up and specialist quickly tapped yes.The clinicians troubleshot together and there was no patient harm.

• Brand Name: QUANTUM WORKSTATION 12" ELITE
• Common Device Name: MONITOR/CONSOLE
• 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: 19948748
• Report Number: 3006073153-2024-00039
• Device Sequence Number: 7244886
• Product Code: DRY
• UDI-Device Identifier: 05060434422309
• UDI-Public: 05060434422309
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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: 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: 07/10/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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