Quantum QFS4-ST-200Recalls & reported problems
Spectrum Medical Limited · Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 2.0m · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05060434421876), received between Jul 5, 2024 and May 1, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Sensing Problem2
- False Positive Result1
- Incorrect Measurement1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Over-Sensing1
- Pumping Stopped1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Reduced Blood Flow1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Incorrect Measurement
USER REPORTED INACCURATE VALUES FROM VENOUS FLOW PROBE. THE VALUES WERE REPORTED TO FLUCTUATE WHILE COMPLETELY CLAMPED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056212 ↗MalfunctionApr 16, 2026Device Sensing Problem
USER REPORTED THAT THE SAFE FLOW CHANNEL WAS UNAVAILABLE WHEN THE USER WAS IN SAFE FLOW MODE. THIS CONSTITUTES AN ERROR THAT IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903745 ↗MalfunctionMar 23, 2026Over-Sensing
USER REPORTED THAT THE DEVICE INCORRECTLY TRIGGERED THE SAFE FLOW MODE WHICH CAUSED AN UNINTENDED PUMP STOP. THERE WAS NO PATIENT HARM; HOWEVER, THE EVENT IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661122 ↗MalfunctionJan 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
USER REPORTED A DISAGREEMENT IN MEASURED FLOW BETWEEN TWO FLOW PROBES. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS THIS TYPE OF EVENT TO BE REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220992 ↗MalfunctionOct 27, 2025False Positive Result; False Positive Result
USER REPORTED THAT THE FLOW PROBE DOOR OPENED ON ITS OWN DURING USE, CAUSING A FALSE POSITIVE BUBBLE ALARM. THE DEVICE WAS CONTINUED TO BE USED TO COMPLETE THE CASE SUCCESSFULLY. WE CONSIDER BLOOD FLOW INTERRUPTIONS TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389174 ↗MalfunctionOct 24, 2025Device Sensing Problem; Device Sensing Problem
USER REPORTED THAT THE DEVICE TRIGGERED A FALSE POSITIVE BUBBLE DETECTION. A BACK UP WAS USED TO COMPLETE THE CASE SUCCESSFULLY. WE CONSIDER BLOOD FLOW INTERRUPTIONS TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379242 ↗MalfunctionJul 5, 2024Pumping Stopped; Pumping Stopped
USER REPORTED THAT THE ARTERIAL FLOW PROBE ALERTED MULTIPLE TIMES, FOLLOWED BY PUMP STOP THEN RETROGRADE FLOW. THE USER COULD NOT RESET THE BUBBLE STOP AND SWITCHED OUT THE FLOW PROBE. ONCE THE FLOW PROBE WAS SWITCHED OUT, THE USER WAS ABLE TO REENGAGE FLOW. THE USER SAID THE TOUCHSCREEN WAS UNRESPONSIVE UNTIL THEY SWITCHED OUT THE FLOW PROBES. THE PATIENT WAS WITHOUT FLOW FOR MINUTES.
Patient problems: Reduced Blood Flow
MAUDE report 19678774 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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