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	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Safe flow alarm started 'flickering' on and off, after circulating fluid for around 1.5hr.The perfusionist opted to replace the level sensor before going on bypass.
Additional Manufacturer Narrative
Sensor tested no fault could be reproduced.Sensor returned to ltd for investigation.Sensor recalibrated and firmware update by ltd.
Event or Problem Description
Safe flow alarm started 'flickering' on and off, after circulating fluid for around 1.5hr.The perfusionist opted to replace the level sensor before going on bypass.

• 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; comerce road; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer Contact: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 20470898
• Report Number: 3006073153-2024-00067
• Device Sequence Number: 7255098
• 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): 10/15/2024

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