MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM FLOW SENSOR (ACCESSORY TO QUANTUM PUMP CONSOLE)

Model Number	QFS4
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The level sensor's lights were on and qws set to safe flow level.The pump rpm kicked into flow regulation during priming several times.The perfusionists replaced the tape and resolved this issue.However, this happened again while they were on bypass.The alarm is showing flashing "s" but rpm never decreased.Arterial and venous flow stayed stable during these events.They checked the connections and made sure everything was connected tightly.The probe doesn't have visible damage when they inspected.The level sensor was being used for the rest of the case.
Additional Manufacturer Narrative
Although during the investigation the flow sensor appeared to be working and reading, out of precaution the sensor was disposed of and replaced with a new one.

• Brand Name: QUANTUM FLOW SENSOR (ACCESSORY TO QUANTUM PUMP CONSOLE)
• 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: 21281084
• Report Number: 3006073153-2025-00026
• Device Sequence Number: 15783079
• Product Code: DRY
• UDI-Device Identifier: 05060434422002
• UDI-Public: 05060434422002
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/31/2025

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: QFS4
• Device Catalogue Number: 51-000078-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/31/2025
• 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