MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM LEVEL SENSOR

Model Number	QLV1
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the level sensor stopped working, preventing the main pump from shutting down when the level was too low.The perfusionist replaced the sensor and there were no consequences for the patient.
Additional Manufacturer Narrative
The investigation performed on the returned sensor did not reveal any cracks or gaps in sensor housing, while liquid ingress residue was visible in transparent dome of yellow head.The root cause of the reported issue was the accidental liquid ingress that temporary compromised the functioning of the sensor.After device return, the liquid in fact dried, and the sensor worked again as expected.

• Brand Name: QUANTUM LEVEL SENSOR
• Common Device Name: LEVEL SENSOR
• 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: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 24617420
• Report Number: 3006073153-2026-00082
• Device Sequence Number: 10164030
• Product Code: DRY
• UDI-Device Identifier: 05060434420893
• UDI-Public: 05060434420893
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: QLV1
• Device Catalogue Number: 43-000889-00
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown