MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM LEVEL SENSOR 2.0M - SINGLE HEAD

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	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Perfusionist complained of multiple 'safe flow' level alarms when blood volume in reservoir was sufficient (higher than level of the sensor cradle).These were coinciding with the addition of crystalloid volume to the reservoir throughout the case.Additionally, the perfusionist complained of a protected flow level alarm approximately 20 seconds after the addition of packed red cells to the reservoir.The pump stopped momentarily but restarted almost immediately.When weaning from bypass (manually with a tubing clamp), flow had been reduced to around 1lpm; surgeon requested to come back up to 3lpm.Perfusionist released clamp and increased flow to 3lpm.Reported 'safe flow' again with adequate volume in reservoir.
Event or Problem Description
Perfusionist complained of multiple 'safe flow' level alarms when blood volume in reservoir was sufficient (higher than level of the sensor cradle).These were coinciding with the addition of crystalloid volume to the reservoir throughout the case.Additionally, the perfusionist complained of a protected flow level alarm approximately 20 seconds after the addition of packed red cells to the reservoir.The pump stopped momentarily but restarted almost immediately.When weaning from bypass (manually with a tubing clamp), flow had been reduced to around 1lpm; surgeon requested to come back up to 3lpm.Perfusionist released clamp and increased flow to 3lpm.Reported 'safe flow' again with adequate volume in reservoir.
Additional Manufacturer Narrative
Sensor tested no fault could be reproduced.Sensor returned to ltd for investigation.Sensor recalibrated and firmware update by ltd.

• Brand Name: QUANTUM LEVEL SENSOR 2.0M - SINGLE HEAD
• Common Device Name: LEVEL SENSOR
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; ashville business park; commerce road; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; ashville business park; commerce road; gloucester, gloucestershire GL29Q L; GB GL29QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 20470891
• Report Number: 3006073153-2024-00066
• Device Sequence Number: 7255096
• Product Code: DTW
• UDI-Device Identifier: 05060434421890
• UDI-Public: 05060434421890
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K202733
• 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
• Report Date (Section B): 10/14/2024

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: QLS1-200
• Device Catalogue Number: 51-000069-00
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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