MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM RESERVOIR LEVEL SENSOR - SINGLE HEAD 2.0M; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Model Number	QLS1-200
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported that the safe flow level was triggered when adding crystalloid into the reservoir.The event self-resolved quickly and there was no patient harm.
Additional Manufacturer Narrative
Investigation is pending return of the device.
Additional Manufacturer Narrative
Investigation is pending return of the device.Follow-up #1: determination of root-cause is pending the result of the investigation.
Event or Problem Description
The user reported that the safe flow level was triggered when adding crystalloid into the reservoir.The event self-resolved quickly and there was no patient harm.
Additional Manufacturer Narrative
During investigation, sensor was confirmed to sync as expected and respond to the presence or absence of liquid.The reported fault is believed to be caused by a use error in which the blood sync was performed prior to the blood and prime solution being fully mixed.Users are advised to perform the blood sync two (2) minutes after initiating bypass to allow sufficient time for the blood and priming solution to mix thoroughly.There was no problem detected with the device.
Event or Problem Description
The user reported that the safe flow level was triggered when adding crystalloid into the reservoir.The event self-resolved quickly and there was no patient harm.

• Brand Name: QUANTUM RESERVOIR LEVEL SENSOR - SINGLE HEAD 2.0M
• 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: 22382395
• Report Number: 3006073153-2025-00155
• Device Sequence Number: 9355066
• Product Code: DRY
• UDI-Device Identifier: 05060434421890
• UDI-Public: 05060434421890
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K173591
• 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
• Report Date (Section B): 08/25/2025

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: QLS1-200
• Device Catalogue Number: 51-000069-00
• Device Lot Number: KP1000031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 06/06/2025; 06/06/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/01/2025; 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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