MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QTM LEVEL SENSOR 2.0M - SINGLE HEAD; RESERVOIR LEVEL SENSOR

Model Number	QLS1-200
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that during a case, the pump was stopped as the safe flow bubble detector had triggered.The user noticed that the level sensor had not recognised that the reservoir level had dropped below the protected level which should have stopped the pump prior to the safe flow bubble detector.Once the pump stopped, the reservoir volume returned, the safe flow bubble alarm was cleared, the pumped restarted and the case continued without issue.The pump was stopped for less than 20 seconds.Testing the level sensor afterwards, the user physically manipulated the sensor and saw the leds intermittently flash on and off.The user opted to change out the level sensor.There was no patient harm as a result of this issue.
Additional Manufacturer Narrative
Investigation of the logs corroborate the events described by the user.No physical damage found on the device, further functionality testing found no issue, the level sensor triggered as expected.Root cause suspected to be an improperly attached level sensor cradle (holds level sensor against reservoir).

• Brand Name: QTM LEVEL SENSOR 2.0M - SINGLE HEAD
• 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: 22607334
• Report Number: 3006073153-2025-00182
• Device Sequence Number: 14826329
• 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): 07/25/2025

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: Other
• 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: 06/26/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown