Quantum QFS3-ST-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05060434421869), received between Jan 30, 2025 and Apr 22, 2026 — classified as 4 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Over-Sensing

  USER REPORTED THAT UPON STARTING DELIVERY OF CARDIOPLEGIA, THE ARTERIAL BUBBLE WAS TRIGGERED, WHICH CAUSED THE PUMP TO STOP AS A SAFETY MEASURE. USER ASSESSED THE CIRCUIT AND DID NOT FIND EVIDENCE OF AIR, SO THE USER CLEARED THE ALARM AND RESUMED SUPPORT TO THE PATIENT. USER REPORTED THAT THIS OCCURRED TWICE MORE DURING CARDIOPLEGIA DELIVERY. THE USER ADJUSTED THE SETTINGS FOR BUBBLE INTERVENTION FROM "SMALL" TO "MEDIUM," WHICH PREVENTED FURTHER PUMP STOPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952607 ↗
• MalfunctionOct 23, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT THE BUBBLE DETECTOR WENT OFF EXCESSIVELY DURING A CASE. THERE WAS NO PATIENT HARM; HOWEVER, THIS EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366697 ↗
• MalfunctionJan 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272377 ↗
• MalfunctionJan 30, 2025Incorrect Measurement; Incorrect Measurement

  USER REPORTED THEIR FLOW PROBE WAS PROVIDING AN INCORRECT READING, COMPARED TO OTHER PROBES. WE CONSIDER INCORRECT MEASUREMENT FROM THE SENSOR TO BE REPORTABLE. DESPITE THIS HAPPENING DURING A CASE, THE PLANNED RISK CONTROL OF SWAPPING FOR A BACK UP DEVICE WAS EXECUTED SUCCESSFULLY TO ENSURE NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271716 ↗