Quantum QSOL (REF 51-000022-02)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05060434424044), received between Jul 24, 2025 and Dec 19, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Pumping Problem; Pumping Problem

  USER REPORTED AN OCCLUDER MALFUNCTION DURING THE PROCEDURE. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS OCCLUDER ERRORS TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850028 ↗
• MalfunctionDec 11, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE USER REPORTED THAT EXCESS VOLUME WAS DELIVERED TO THE PATIENT WHEN A SET VOLUME OF FLUID TO BE DELIVERED HAD BEEN SELECTED. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780208 ↗
• MalfunctionDec 5, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  USER REPORTED BOBBIN FAILURE DURING CASE, WHICH IS CONSIDERED REPORTABLE PER SPECTRUM MEDICAL'S CRITERIA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730439 ↗
• MalfunctionDec 4, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  USER REPORTED THAT THE ARTERIAL OCCLUDER WOULD NOT FULLY CLOSE AND THEY HAD TO USE A CLAMP. THERE WAS NO PATIENT HARM; THEREFORE, THE EVENT IS NOT CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723666 ↗
• MalfunctionOct 31, 2025Restricted Flow rate; No Flow; Restricted Flow rate; No Flow

  SPECTRUM MEDICAL STAFF WAS PRESENT TO TRAIN THE PERFUSIONISTS IN THE 3RD WEEK OF INSTALLATION. THE SYSTEM WAS SET CORRECTLY AND IN INITIATION MODE. BEFORE STARTING WITH CPB, 50ML WAS GIVEN FOR 2-3 TIMES AND ALL WAS GOOD. WHEN THE PERFUSIONIST STARTED BYPASS AND INCREASED THE FLOW, THE VEIN QSO WAS OPENED TO PRODUCE A MINIMAL FLOW, BUT THE ARTERY QSO DID NOT OPEN (LED FLASHING). THEY DECIDED TO EXIT FROM THE INITIATION MODE, AND THE VEIN OCCLUDER WENT TO A FULLY OPEN POSITION, HOWEVER THE ARTERY OCCLUDER REMAINED CLOSED. FLOW WAS STOPPED, SPECTRUM MEDICAL STAFF REMOVED THE TUBES MANUALLY FROM THE QSO AND THE FLOW TO THE PATIENT WAS RESTORED. AFTER THAT, THE PERFUSIONIST WANTED TO REUSE THE ARTERIAL QSO. BEFORE REINSERTING THE TUBE IN THE QSO, THEY DID THE CARRIAGE TEST AND THE FUNCTION WAS OK. AFTER THAT, ALL THE FEATURES WERE CORRECT AND THEY USED THE QSO UNTIL THE END OF THE OPERATION WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436263 ↗
• MalfunctionJul 24, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  USER REPORTED THAT THE OCCLUDER DID NOT BEHAVE AS EXPECTED WHEN TRYING TO STOP VENOUS FLOW. THERE WAS NO PATIENT HARM; HOWEVER, IF THE EVENT WERE TO RECUR, IT COULD RESULT IN POTENTIAL PATIENT HARM, SO THIS EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587937 ↗
• MalfunctionJul 24, 2025Infusion or Flow Problem; Infusion or Flow Problem

  USER REPORTED PUMP FLOW INTERRUPTION CAUSED BY THE OCCLUDER WHEN ENTERING WEANING MODE, WHEN THE UNITS WERE SET TO ML/MIN. THIS DID NOT OCCUR WHEN THE UNITS WERE SET TO L/MIN. WE CONSIDER INTERRUPTIONS TO THE BLOOD FLOW TO BE REPORTABLE, DESPITE NO PATIENT INVOLVEMENT IN THIS INSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585541 ↗