Quantum QFS5-ST-075Recalls & reported problems
Spectrum Medical Limited · Quantum Flow Sensor - ID 1/2" x Wall 3/32"(OD11/16") 0.75m · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060434422019), received between Nov 7, 2024 and Oct 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Sensing Problem1
- Failure to Sense1
- Incorrect Interpretation of Signal1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Failure to Sense; Failure to Sense
USER REPORTED THAT THE DEVICE FAILED TO DETECT AIR IN THE VENOUS LINE, UNTIL IT WAS REMOVED AND REPLACED. WE CONSIDER FAILURE TO DETECT/STOP GROSS EMBOLI TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23347808 ↗MalfunctionJan 29, 2025Device Sensing Problem; Device Sensing Problem
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21262950 ↗MalfunctionNov 7, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal
USER REPORTED THAT DURING THE SET UP THE VENOUS FLOW SENSOR WAS SHOWING FLOW WHILST THE LINE WAS CLAMPED AND THERE WAS NO FLOW. DURING THE PROCEDURE THE SENSOR STOPPED WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20629875 ↗
Other Console, Heart-Lung Machine, Cardiopulmonary Bypass devices
- Terumo® Advanced Perfusion System 1 801188Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass3 recalls447 reports
- MAQUET CARDIOHELP CARDIOHELP-iMaquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS5 recalls2 deaths64 reports
- MAQUET CARDIOHELP CARDIOHELP SystemMaquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS4 recalls18 deaths107 reports
- Terumo® Advanced Perfusion System 1 816300Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass300 reports
- Terumo® Advanced Perfusion System 1 801763Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass1 death230 reports
- Terumo® Advanced Perfusion System 1 816571Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass230 reports
- ESSENZ HLMLivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS1 recall1 death110 reports
- Terumo® Advanced Perfusion System 1 5773Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass1 recall78 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page