Quantum QLV1Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 05060434420893), received between Oct 20, 2021 and Jun 15, 2026 — classified as 69 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (29 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 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Device Sensing Problem

  USER REPORTED THAT THE LEVEL SENSOR DID NOT OPERATE AS EXPECTED WHEN IN SAFE FLOW MODE, BUT IT COULD BE USED PROPERLY IN PROTECTED FLOW MODE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504068 ↗
• MalfunctionJun 15, 2026Device Sensing Problem

  USER REPORTED THAT THE LEVEL SENSOR WAS NOT TRIGGERING THE EXPECTED RESPONSE. THE USER REPLACED THE LEVEL SENSOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504032 ↗
• MalfunctionMay 14, 2026Device Sensing Problem

  USER REPORTED THAT THE SAFETY MEASURE OF PUMP INTERVENTION DID NOT TRIGGER WHEN THE VOLUME WAS BELOW THE SENSOR. 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 25175186 ↗
• MalfunctionMay 7, 2026Failure to Sense

  THE USER REPORTED THAT DURING THE CASE, THE SENSOR LIGHT FLASHED THOUGH THE VOLUME HAD FALLEN BELOW THE SET LEVEL. THE FLOW SENSOR AT THE RESERVOIR OUTLET STOPPED THE PUMP. NO ADVERSE CONSEQUENCES OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25109999 ↗
• MalfunctionApr 17, 2026Device Sensing Problem

  USER REPORTED THE LEVEL SENSOR WAS NOT RESPONDING CORRECTLY TO STIMULUS, WHICH IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911197 ↗
• MalfunctionMar 30, 2026No Device Output

  USER REPORTED THAT THE SENSOR INDICATED THE VOLUME PASSED THE SAFE LEVEL THRESHOLD, BUT THE SYSTEM SOFTWARE DID NOT RESPOND AS EXPECTED. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728779 ↗
• MalfunctionMar 23, 2026Electrical Shorting

  USER REPORTED THAT THE LEVEL SENSOR WAS INCORRECTLY ALARMING, WHICH COULD CAUSE DECREASED FLOW OR AN UNNECESSARY PUMP STOP. THERE WAS NO PATIENT HARM; HOWEVER, THIS IS CONSIDERED A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661511 ↗
• MalfunctionMar 17, 2026Failure to Sense

  DURING THE PROCEDURE, THE LEVEL SENSOR STOPPED WORKING, PREVENTING THE MAIN PUMP FROM SHUTTING DOWN WHEN THE LEVEL WAS TOO LOW. THE PERFUSIONIST REPLACED THE SENSOR AND THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617420 ↗
• MalfunctionMar 9, 2026Failure to Sense

  THE USER REPORTED THE LEVEL SENSOR MALFUNCTIONING DURING THE PROCEDURE: THE LEVEL SENSOR FAILED TO STOP THE PUMP ALTHOUGH IT HAD BEEN ACTIVATED. NO ADVERSE CONSEQUENCES OCCURRED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543205 ↗
• MalfunctionMar 5, 2026Decreased Pump Speed

  USER REPORTED FALSE LEVEL ALARM FROM LEVEL SENSOR, WHICH CAN CAUSE THE PUMP TO UNNECESSARILY STOP OR SLOW. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519780 ↗
• MalfunctionFeb 12, 2026Device Sensing Problem

  USER REPORTED THAT THE LEVEL SENSOR TRIGGERED CORRECTLY, BUT WOULD NOT RESET ONCE VOLUME RETURNED. THE USER HAD TO DISABLE THE SENSOR TO RETURN VOLUME TO THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323151 ↗
• MalfunctionDec 22, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED LEVEL SENSOR WAS NOT RESPONDING APPROPRIATELY TO STIMULUS, WHICH CAUSED DECREASE IN FLOW. 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 23865441 ↗
• MalfunctionDec 19, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT THE SAFE FLOW WAS NOT CORRECTLY TRIGGERED BY THE LEVEL SENSOR. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS INCORRECT MEASUREMENTS OF THE LEVEL SENSOR TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850151 ↗
• MalfunctionDec 19, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT THE LEVEL SENSORS WERE NOT WORKING CORRECTLY. THE LEVEL SENSOR CORRECTLY TRIGGERED PROTECTED LEVEL, BUT NOT THE SAFE LEVEL. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849864 ↗
• MalfunctionDec 12, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT THE LEVEL SENSOR DID NOT TRIGGER AN ALERT TO INDICATE A LACK OF FLUID. THIS IS CONSIDERED A REPORTABLE EVENT AS THERE IS POTENTIAL FOR SERIOUS PATIENT HARM TO OCCUR IF THE RESERVOIR WERE TO EMPTY WITHOUT THE USER REALIZING. THERE WAS NO PATIENT HARM IN THIS INSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789673 ↗
• MalfunctionDec 8, 2025Device Sensing Problem; Device Sensing Problem

  THE SAFE FLOW REMAINED PERMANENTLY ENGAGED AND DETECTING FLUID, EVEN WHEN IT WAS NOT ON THE RESERVOIR. NO CONDENSATION/FLUID OR CRACKED HOUSING WAS NOTED ON THE SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741026 ↗
• MalfunctionDec 3, 2025Device Sensing Problem; Device Sensing Problem

  FLOW LEVEL SENSOR HEAD INTERMITTENTLY READING APPROPRIATELY/NOT READING WITH LED FLASHING ON & OFF DESPITE VOLUME ABOVE LEVEL SENSOR HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702950 ↗
• MalfunctionNov 19, 2025Device Sensing Problem; Device Sensing Problem

  THE USER REPORTED A FAULTY LEVEL SENSOR. THE YELLOW SENSOR HEAD DETECTS WITHOUT CONTACT AND REMAINS ILLUMINATED CONTINUOUSLY. THE RED SENSOR HEAD ALSO DETECTS AND LIGHTS UP, ALTHOUGH THE RESERVOIR IS FREE OF ANY LIQUID. THE REPLACEMENT SENSOR WORKED AS EXPECTED. THERE WAS NO PATIENT HARM AS A RESULT OF THIS SUSPECTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592150 ↗
• MalfunctionNov 11, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT THE SAFE LEVEL SENSOR WAS NOT RESPONDING TO FLUID WITHIN THE RESERVOIR. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS INCORRECT MEASUREMENTS FROM THE LEVEL SENSOR TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526018 ↗
• MalfunctionOct 22, 2025Failure to Sense; Failure to Sense

  THE COMPLAINT IS REGARDING AN ISSUE WITH A LEVEL SENSOR DURING PRIMING OR CIRCUIT SETUP OF A PERFUSION MEDICAL DEVICE. THE LEVEL SENSOR WAS REPORTED TO HAVE AN INTERMITTENT SENSITIVITY ISSUE. OCCASIONALLY, IT DID NOT DETECT THE ACTUAL FLUID LEVEL AND THE LED REMAINED ILLUMINATED, INDICATING A FALSE FLUID LEVEL DETECTION. NO PHYSICAL DAMAGE OBSERVED ON THE SENSOR, WITH NO VISIBLE CRACKS OR GAPS ON THE SENSOR HOUSING, AND NO TRACES OF HUMIDITY WERE FOUND INSIDE THE SENSOR HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357584 ↗
• MalfunctionSep 5, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT THE LEVEL SENSOR DID NOT RESPOND AS EXPECTED TO DETECT FLUID. THERE WAS NO PATIENT HARM; HOWEVER, LEVEL SENSOR ERRORS ARE CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976315 ↗
• MalfunctionAug 27, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT THE LEVEL SENSOR DID NOT RESPOND APPROPRIATELY TO THE PROTECTED LEVEL IN THE RESERVOIR WAS PASSED. THERE WAS NO PATIENT HARM; HOWEVER, THIS EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905101 ↗
• MalfunctionAug 27, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  USER REPORTED THE INABILITY TO CONTROL ARTERIAL FLOW DUE TO BEING UNABLE TO EXIT A SENSOR ERROR. THE RESERVOIR FILLED WITH VOLUME, BUT THE USER COULD NOT RETURN VOLUME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904959 ↗
• MalfunctionAug 27, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT THE LEVEL SENSOR WAS NOT ALERTING WHEN FLUID IS NOT DETECTED. THERE WAS NO HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904937 ↗
• MalfunctionAug 21, 2025Protective Measures Problem; Protective Measures Problem

  USER REPORTED THAT THE LEVEL SENSOR WAS LIGHTING UP CORRECTLY, BUT NOT EMPLOYING MITIGATION STRATEGIES (DECREASING RPMS, STOPPING PUMP) WHEN NECESSARY. THERE WAS NO PATIENT INVOLVEMENT AND THUS NO PATIENT HARM; HOWEVER, THIS EVENT IS CONSIDERED REPORTABLE AS THERE COULD BE A RISK OF PATIENT HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864986 ↗