MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QTM LEVEL SENSOR 2.0M - SINGLE HEAD (ACCESSORY TO THE QUANTUM DIAGNOSTIC MODULE); RESERVOIR LEVEL SENSOR

Model Number	QLS1-200
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of logs completed.Logs reveal a sensor link error occurred while blood sync data was loading to the sensor, the pump was stopped due to the error and was expected due to uneven mixing in the reservoir.Error self-rectified after less than 1s.There would be no risk of patient harm as a result of this.Spectrum medical is working on an improvement.
Event or Problem Description
User reported that after 25 seconds of the commencement of bypass, with fluid level above safe flow level and during blood mixing, the level sensor malfunction (10810) alarmed with a pump stop for 4.5 sec.Sensor error self corrected and flows returned to pre-alarm setting.There was no patient harm as a result of this.

• Brand Name: QTM LEVEL SENSOR 2.0M - SINGLE HEAD (ACCESSORY TO THE QUANTUM DIAGNOSTIC MODULE)
• Common Device Name: RESERVOIR LEVEL SENSOR
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 22182781
• Report Number: 3006073153-2025-00139
• Device Sequence Number: 15579730
• Product Code: DRY
• UDI-Device Identifier: 05060434421890
• UDI-Public: 05060434421890
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/11/2025

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
• 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: 05/12/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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