MAUDE Adverse Event Report: SPECTRUM MEDICAL QUANTUM DIAGNOSTIC MODULE; BLOOD GAS MONITOR

Model Number	QLS1-200
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial investigation indicates that the system was in initiation mode so could not disable the level sensor.The level sensor had alarmed and stopped the pump.If the user had disabled initiation mode, the user would have been able to restart the pump.Investigation is to be completed to determine full root cause and determine reason for initial level sensor alarm.
Event or Problem Description
User reported that during bypass, all looked good, but then the pump stopped due to level alarm.According to perfusionist it was not possible to disable the level at all because it was "greyed out".As blood flow was zero and it was not possible to restart the pump, they closed venous and started hand cranking giving volume back to the patient.After that they replaced the cradle of the level sensor.Then spectrum clinical specialist entered room.While reservoir full yellow led was off and red was on.The user disconnected the level sensor and reconnected.The user had to press the sensor better into cradle and then both leds were on.The user continued bypass without further issue.There was no patient harm as a result of this issue.
Event or Problem Description
User reported that during bypass, all looked good, but then the pump stopped due to level alarm.According to perfusionist it was not possible to disable the level at all because it was "greyed out".As blood flow was zero and it was not possible to restart the pump, they closed venous and started hand cranking giving volume back to the patient.After that they replaced the cradle of the level sensor.Then spectrum clinical specialist entered room, while reservoir full yellow led was off and red was on.The user disconnected the level sensor and reconnected.The user had to press the sensor better into cradle and then both leds were on.The user continued bypass without further issue.There was no patient harm as a result of this issue.
Additional Manufacturer Narrative
Initial investigation comprised of a review of the logs, prior to the product returning.This indicated that the system was in initiation mode so could not disable the level sensor.The level sensor had alarmed and stopped the pump.If the user had disabled initiation mode, the user would have been able to restart the pump.Investigation is to be completed to determine full root cause and determine reason for initial level sensor alarm.The testing of the actual device will commence on arrival back to the manufacturer.

• Brand Name: QUANTUM DIAGNOSTIC MODULE
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: edward blogg ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 22019260
• Report Number: 3006073153-2025-00124
• Device Sequence Number: 12956484
• Product Code: DRY
• UDI-Device Identifier: 05060434421890
• UDI-Public: 05060434421890
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 07/14/2025

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
• Device Lot Number: KP1000031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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