Quantum QFS5-ST-200Recalls & reported problems

Spectrum Medical Limited · Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 2.0m · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060434421883), received between Jun 24, 2025 and Jun 24, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unable to Obtain Readings” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Unable to Obtain Readings1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 24, 2025Unable to Obtain Readings; Unable to Obtain Readings
USER REPORTED THAT THE FLOW SENSOR WAS NOT READING MEASUREMENTS AT ALL. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318540 ↗

Device details

UDI-DI	`05060434421883`
Brand	Quantum
Model	QFS5-ST-200
Catalog no.	51-000068-00
Company	Spectrum Medical Limited
Product code	DTQ · Console, Heart-Lung Machine, Cardiopulmonary Bypass
Class	Class 2
FDA submission	K190282
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 27, 2023

Device type (GMDN): Cardiopulmonary bypass system air bubble/fluid level detector

A mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venous drip chamber. The device typically consists of an electronic unit and ultrasonic sensors; it usually triggers alarms and activates automated mechanisms to turn off the blood flow when bubbles are detected or an abnormal fluid level occurs. It is typically an integral part of the cardiopulmonary bypass system.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.