Quantum ® System M ® Flow & Emboli SensorRecalls & reported problems
Spectrum Medical Limited · Tube ID 1/2" x Wall 3/32" (OD 11/16") · 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 05060434420138), received between Jul 9, 2024 and Jul 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (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
Most reported problems
Device problems
- Incorrect Interpretation of Signal1
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.
MalfunctionJul 9, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal
PERFUSIONIST STATED THAT THEY ZEROED THE ARTERIAL, SAFE, AND VENOUS FLOW PROBES PRIOR TO THE START OF THE CASE. HOWEVER, WHEN THEY WERE GETTING READY TO GO ON CPB, THEY NOTICED THAT THE VENOUS FLOW WAS READING 0.6 EVEN THOUGH THE VENOUS OCCLUDER WAS FULLY OCCLUDED. THE PERFUSIONIST CONFIRMED THEY DID NOT SEE VOLUME ENTERING THE RESERVOIR. AFTER THE CASE, THE ARTERIAL LINE WAS MANUALLY CLAMPED, AND THE VENOUS LINE WAS CLAMPED VIA THE VENOUS OCCLUDER. DESPITE THE OCCLUDER BEING FULLY OCCLUDED, THE VENOUS FLOW WAS READING 1.13 LPM. AGAIN, WITH NO DRAINAGE. THE PERFUSIONIST ALSO STATED THAT THEIR SAFE FLOW BUBBLE DETECTOR FIRED TWICE DURING THE CASE AND STOPPED THE PUMP BOTH TIMES. AIR WAS NOT OBSERVED AND THEY WENT BACK ON CPB BY DISABLING THE SAFE FLOW BUBBLE. THE SERIAL NUMBER OF THE VENOUS FLOW PROBE WAS (B)(6) AND SAFE FLOW PROBE WAS (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19699483 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.