MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM FLOW SENSOR

Model Number	QFS5
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The 1/2" venous flow probe appeared to be more than 500ml apart from the arterial flow probe.The clinician ensured that there are no shunts open and has zeroed the flow probes multiple times and it was still significantly off from the arterial probe.
Additional Manufacturer Narrative
Sensor was out of calibration.

• Brand Name: QUANTUM FLOW SENSOR
• Common Device Name: FLOW SENSOR
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: asia lukuc ; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 21262950
• Report Number: 3006073153-2025-00013
• Device Sequence Number: 18553431
• Product Code: DRY
• UDI-Device Identifier: 05060434422019
• UDI-Public: 05060434422019
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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: QFS5
• Device Catalogue Number: 51-000079-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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