MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM FLOW SENSOR (ACCESSORY TO THE QUANTUM DIAGNOSTIC MODULE); BLOOD GAS MONITOR

Model Number	QFS3-ST-200
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the logs found the arterial bubble detection was re-enabled after 19 seconds, indicating suspected user error.Testing of the suspected device was unable to recreate the fault.
Event or Problem Description
User reported that the pump went to zero flow mode when the flow sensor was disconnected from the tubing.This was unexpected and took 30 seconds for the clinical team to realise, during this time the patient was desaturated, until the clinical team restarted the flow.We consider blood flow interruption to be reportable, despite no harm to the patient involved.

• Brand Name: QUANTUM FLOW SENSOR (ACCESSORY TO THE QUANTUM DIAGNOSTIC MODULE)
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: edward blogg ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 21272377
• Report Number: 3006073153-2025-00021
• Device Sequence Number: 12780083
• Product Code: DRY
• UDI-Device Identifier: 05060434421869
• UDI-Public: 05060434421869
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 01/30/2025

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: QFS3-ST-200
• Device Catalogue Number: 51-000066-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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