ACUMEN IQ AIQFM10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103205824), received between Jun 9, 2025 and Mar 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionMar 25, 2026Infusion or Flow Problem

  AS REPORTED, DURING USE IN PATIENT, WITH THIS HEMOSPHERE FLUID METER CONNECTED TO A HEMOSPHERE MONITOR, THE VOLUME OF FLUID WAS NOT TRACKED (SEE VIDEO ATTACHED). IT WAS DISCONNECTED AND CONNECTED SEVERAL TIMES BUT THE ISSUE REMAINED. IT WAS SOLVED REPLACING THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684767 ↗
• MalfunctionDec 5, 2025Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED, DURING USE THIS ACUMEN FLUID METER DID NOT INITIALIZE AND DISPLAYED BOLUS VOLUME ADMINISTERED AND THE ERROR MESSAGE "FLOW RATE DETECTED TOO HIGH", EVEN THOUGHT THE LINE WAS CLOSED AND NO BOLUS HAD BEEN INJECTED INTO THE PATIENT SINCE AS PER USER BEST PRACTICES THE LINE IS NOT OPENED UNTIL THE SYSTEM INDICATES THAT A BOLUS CAN BE INJECTED. CABLE WAS DISCONNECTED AND RECONNECTED SEVERAL TIMES AND ALSO REPLACED WITH A NEW ONE WITHOUT SUCCESS. THE ISSUE WAS SOLVED WHEN THE FLUID METER WAS CHANGED. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726162 ↗
• MalfunctionJun 9, 2025Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED, WHEN PERFORMING THE BOLUS WITH THIS FLUID METER, THE FLUID WAS INFUSED CORRECTLY BUT IT WAS NOT TRACKED. LATER, IT DETECTED THE PASSAGE OF FLUID WHEN EVERY LINE WAS CLOSED AND NOTHING WAS BEING INJECTED. THERE WAS NO INCORRECT FLUID ADMINISTRATION TO THE PATIENT; THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165407 ↗