Quantum QFS2-ST-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060434421852), received between Jan 26, 2023 and Feb 6, 2026 — classified as 1 death, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Pumping Stopped

  USER REPORTED THAT A BUBBLE WAS DETECTED WITHOUT THE PRESENCE OF AIR. THERE WAS NO PATIENT HARM, BUT THIS TYPE OF EVENT IS CONSIDERED REPORTABLE SINCE IT CAUSES A PUMP STOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278796 ↗
• MalfunctionJan 31, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED ISSUES RELATED TO DEVICE SENSING PROBLEMS USING SENSORS. INABILITY TO CORRECTLY SENSE IS CONSIDERED A REPORTABLE EVENT. THERE WAS NO PATIENT HARM AS A RESULT OF THESE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282622 ↗
• DeathJan 26, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  FLOW PROBE SENSOR, ECMO COORDINATOR, REPORTED THAT THEY HAD A 1/4" FLOW PROBE THAT WAS READING ABOUT HALF OF THE ACTUAL FLOW. THE FLOW PROBE FS2000138 WAS THE ARTERIAL FLOW PROBE, AND THE ENTIRE CASE IT WAS READING AROUND .200 LPM, WHICH WAS THE TARGET FLOW THEY ALSO HAD A VENOUS FLOW PROBE (MEASURED PRE-SHUNT SO THISSHOULD BE VERY CLOSE TO THE ART FLOW) AND AN "ALT FLOW" PROBE (SHUNT FLOW). AN ECMO SPECIALIST EVENTUALLY NOTICED THE DISCREPANCY BETWEEN ART AND VEN FLOWS (NO ALARMS SET OR CHARTING OF VEN AND ALT ROUTINELY). THEY DID SOME TROUBLE SHOOTING BY ATTACHING ALL FLOW PROBES TO THE ARTERIAL LINE, AND THE ART FLOW WAS READING ABOUT HALF OF WHAT THE OTHER TWO FLOW PROBES WERE READING. THEY THEN REPLACED FS2000138 WITH A NEW FLOW PROBE, AND THIS WAS READING THE SAME AS THE VENOUS FLOW PROBE. THE SPECIALIST THAT SET UP THE PUMP REPORTED ZEROING ALL FLOWS BEFORE THE CASE. THEY DID NOT ZERO THE REPLACEMENT FLOW PROBE BECAUSE THEY WERE ON SUPPORT.

  Patient problems: Insufficient Information

  MAUDE report 16245369 ↗