Quantum QLS1-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05060434421890), received between Oct 17, 2024 and Apr 28, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Failure to Sense

  THE USER REPORTED A LEVEL SENSOR INCORRECT MEASUREMENT DURING THE CASE. NO ADVERSE CONSEQUENCES OCCURRED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015711 ↗
• MalfunctionJul 25, 2025Failure to Sense; Failure to Sense

  USER REPORTED THAT DURING A CASE, THE PUMP WAS STOPPED AS THE SAFE FLOW BUBBLE DETECTOR HAD TRIGGERED. THE USER NOTICED THAT THE LEVEL SENSOR HAD NOT RECOGNISED THAT THE RESERVOIR LEVEL HAD DROPPED BELOW THE PROTECTED LEVEL WHICH SHOULD HAVE STOPPED THE PUMP PRIOR TO THE SAFE FLOW BUBBLE DETECTOR. ONCE THE PUMP STOPPED, THE RESERVOIR VOLUME RETURNED, THE SAFE FLOW BUBBLE ALARM WAS CLEARED, THE PUMPED RESTARTED AND THE CASE CONTINUED WITHOUT ISSUE. THE PUMP WAS STOPPED FOR LESS THAN 20 SECONDS. TESTING THE LEVEL SENSOR AFTERWARDS, THE USER PHYSICALLY MANIPULATED THE SENSOR AND SAW THE LEDS INTERMITTENTLY FLASH ON AND OFF. THE USER OPTED TO CHANGE OUT THE LEVEL SENSOR. THERE WAS NO PATIENT HARM AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607334 ↗
• MalfunctionJul 2, 2025Device Sensing Problem; Device Sensing Problem

  THE USER REPORTED THAT THE SAFE FLOW LEVEL WAS TRIGGERED WHEN ADDING CRYSTALLOID INTO THE RESERVOIR. THE EVENT SELF-RESOLVED QUICKLY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382395 ↗
• MalfunctionJun 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  USER REPORTED THAT AFTER 25 SECONDS OF THE COMMENCEMENT OF BYPASS, WITH FLUID LEVEL ABOVE SAFE FLOW LEVEL AND DURING BLOOD MIXING, THE LEVEL SENSOR MALFUNCTION (10810) ALARMED WITH A PUMP STOP FOR 4.5 SEC. SENSOR ERROR SELF CORRECTED AND FLOWS RETURNED TO PRE-ALARM SETTING. THERE WAS NO PATIENT HARM AS A RESULT OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182781 ↗
• MalfunctionJun 11, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT PROTECTED LEVEL TRIGGERED INCORRECTLY ON COMMENCEMENT OF BYPASS. NO ERROR DISPLAYED JUST TRIGGERING PROTECTED LEVEL ALARM. USER DISABLED LEVEL AND SYNCED WITH BLOOD. REST OF CASE CONTINUED WITHOUT ISSUE. NO PATIENT HARM AS A RESULT OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182780 ↗
• MalfunctionMay 14, 2025Output Problem; Output Problem

  USER REPORTED THAT DURING BYPASS, ALL LOOKED GOOD, BUT THEN THE PUMP STOPPED DUE TO LEVEL ALARM. ACCORDING TO PERFUSIONIST IT WAS NOT POSSIBLE TO DISABLE THE LEVEL AT ALL BECAUSE IT WAS "GREYED OUT". AS BLOOD FLOW WAS ZERO AND IT WAS NOT POSSIBLE TO RESTART THE PUMP, THEY CLOSED VENOUS AND STARTED HAND CRANKING GIVING VOLUME BACK TO THE PATIENT. AFTER THAT THEY REPLACED THE CRADLE OF THE LEVEL SENSOR. THEN SPECTRUM CLINICAL SPECIALIST ENTERED ROOM. WHILE RESERVOIR FULL YELLOW LED WAS OFF AND RED WAS ON. THE USER DISCONNECTED THE LEVEL SENSOR AND RECONNECTED. THE USER HAD TO PRESS THE SENSOR BETTER INTO CRADLE AND THEN BOTH LEDS WERE ON. THE USER CONTINUED BYPASS WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019260 ↗
• MalfunctionOct 17, 2024Device Sensing Problem; Device Sensing Problem

  SAFE FLOW ALARM STARTED 'FLICKERING' ON AND OFF, AFTER CIRCULATING FLUID FOR AROUND 1.5HR. THE PERFUSIONIST OPTED TO REPLACE THE LEVEL SENSOR BEFORE GOING ON BYPASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20470898 ↗
• MalfunctionOct 17, 2024Device Sensing Problem; Device Sensing Problem

  PERFUSIONIST COMPLAINED OF MULTIPLE 'SAFE FLOW' LEVEL ALARMS WHEN BLOOD VOLUME IN RESERVOIR WAS SUFFICIENT (HIGHER THAN LEVEL OF THE SENSOR CRADLE). THESE WERE COINCIDING WITH THE ADDITION OF CRYSTALLOID VOLUME TO THE RESERVOIR THROUGHOUT THE CASE. ADDITIONALLY, THE PERFUSIONIST COMPLAINED OF A PROTECTED FLOW LEVEL ALARM APPROXIMATELY 20 SECONDS AFTER THE ADDITION OF PACKED RED CELLS TO THE RESERVOIR. THE PUMP STOPPED MOMENTARILY BUT RESTARTED ALMOST IMMEDIATELY. WHEN WEANING FROM BYPASS (MANUALLY WITH A TUBING CLAMP), FLOW HAD BEEN REDUCED TO AROUND 1LPM; SURGEON REQUESTED TO COME BACK UP TO 3LPM. PERFUSIONIST RELEASED CLAMP AND INCREASED FLOW TO 3LPM. REPORTED 'SAFE FLOW' AGAIN WITH ADEQUATE VOLUME IN RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20470891 ↗