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

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	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the device logs found that level sensor alarmed due to the uneven mixing of blood in the reservoir.The error self rectified afterwhich the system functioned as expected.There was no patient harm.Spectrum medical is working on an improvement to this issue.
Event or Problem Description
User reported that protected level triggered incorrectly on commencement of bypass.No error displayed just triggering protected level alarm.User disabled level and synced with blood.Rest of case continued without issue.No patient harm as a result of this.

• Brand Name: QTM LEVEL SENSOR 2.0M - SINGLE HEAD (ACCESSORY TO 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: 22182780
• Report Number: 3006073153-2025-00140
• Device Sequence Number: 8505481
• 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