Quantum QSOL (REF 51-000022-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060434423436), received between Jan 29, 2025 and Jan 31, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Positioning Problem; Positioning Problem

  USER REPORTED THAT DURING A CASE A USER HAD SLOWLY ATTEMPTED TO CLOSE THE VENOUS OCCLUDER. WHEN THE USER BEGAN TO TURN THE KNOW THE OCCLUDER IMMEDIATELY CLOSED. THE USER RESET AND THEN TRIED AGAIN. THE ISSUE HAPPENED AGAIN. THERE WAS NO PATIENT HARM AS A RESULT OF THIS INCIDENT. SPECTRUM MEDICAL CONSIDERS A SUDDEN OR UNINTENTIONAL DECREASE IN BLOOD FLOW A REPORTABLE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281736 ↗
• MalfunctionJan 29, 2025Activation Failure; Activation Failure

  CUSTOMER REPORTED THAT WHILE TESTING BUBBLE DETECTION, THE ARTERIAL CLAMP DIDN'T CLAMP WHEN DETECTING A BUBBLE. THIS HAPPENED 3 TIMES IN A ROW AND WORKED FINE AFTERWARDS. FROM THE VIDEO, IT SEEMS THAT THE ARTERIAL CLAMP IS RELEASED BUT THE QWS SHOW THAT IT IS IN THE OPEN POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264511 ↗