Quantum QFS4-ST-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05060434422002), received between Jan 31, 2025 and Mar 18, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026False Alarm

  THIS EVENT RELATES TO THE ARTERIAL FLOW CHANNEL BECOMING UNAVAILABLE DURING WEANING. THE PERFUSIONIST MENTIONED THAT HE HAD AN ALARM OF ARTERIAL FLOW CHANNEL BEING UNAVAILABLE AND THAT THE MACHINE WAS ALARMING AND HE COULD NOT CLEAR NOR OVERRIDE THE ERROR. THE PERFUSIONIST HAD TO GO OUT OF WEANING MODE AND FINISH THE CASE MANUALLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625672 ↗
• MalfunctionSep 10, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED ERRONEOUS BUBBLE DETECTION. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS THIS EVENT TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018971 ↗
• MalfunctionJul 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  BUBBLE ALARM WAS TRIGGERED AFTER THE CROSS-CLAMP WAS REMOVED DURING A CLINICAL CASE. ACCORDING TO THE PERFUSIONIST, THERE WAS NO VISIBLE AIR IN THE CIRCUIT, AND ALL OTHER SAFETY SYSTEMS FUNCTIONED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530402 ↗
• MalfunctionJul 10, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED A DIFFERENCE IN FLOW BETWEEN THE SAFE FLOW PROBE AND ARTERIAL FLOW PROBE NOTED TO BE 0.5 L/MIN AT 4.0L/MIN OF FLOW. THIS FLOW PROBE WAS ABLE TO BE IDENTIFIED AND SWAPPED WITH A BACK UP DURING THE CASE. THERE WAS NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466413 ↗
• MalfunctionJun 17, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE THE BUBBLE DETECTOR TRIGGERED AFTER THE USER HAD FINISHED PRIMING. AS NO AIR WAS VISIBLE, THIS WAS TREATED AS A FALSE POSITIVE. THERE WAS NO HARM TO THE PATIENT INVOLVED. WE CONSIDER INCORRECT MEASUREMENT FROM BUBBLE SENSOR TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235924 ↗
• MalfunctionJan 31, 2025Device Sensing Problem; Device Sensing Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281084 ↗