Quantum QHC1Recalls & reported problems
Spectrum Medical Limited · Quantum Heater Cooler · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is the Quantum Heater Cooler, a device that controls patient temperature during heart surgery. The 54 reports mostly describe the unit failing to cool properly or losing its set point during a procedure, with a few noting fluid or blood leaking from it. No deaths and no injuries were reported. There are no recalls naming this device. Reports have dropped noticeably, from 38 in the earlier 12 months to 15 in the most recent.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 05060434420961), received between Sep 3, 2024 and Sep 10, 2026 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Insufficient Cooling” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Cooling29
- Temperature Problem20
- Device Contamination with Body Fluid2
- Fluid/Blood Leak1
- Insufficient Heating1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Insufficient Cooling
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721071 ↗MalfunctionApr 30, 2026Fluid/Blood Leak
USER REPORTED THAT THE HEATER-COOLER DE-PRIMED DURING THE CASE AND NOTICED LEAKAGE. THERE WAS NO HARM TO THE PATIENT; HOWEVER, DEVICE REPLACEMENT WAS REQUIRED DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25043714 ↗MalfunctionMar 23, 2026Insufficient Cooling
USER REPORTED THAT THE HEATER-COOLER DID NOT REACH THE SET-POINT. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660841 ↗MalfunctionMar 13, 2026Insufficient Cooling
USER REPORTED DEVICE WOULD NOT COOL CARDIOPLEGIA DOSE. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589817 ↗MalfunctionMar 2, 2026Insufficient Cooling
USER REPORTED THAT THE DEVICE FAILED TO COOL AS EXPECTED DURING THE CASE. THIS TYPE OF EVENT IS CONSIDERED REPORTABLE PER SPECTRUM MEDICAL'S CRITERIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24480623 ↗MalfunctionFeb 20, 2026Insufficient Cooling
USER REPORTED THAT THE DEVICE ACTED AS EXPECTED DURING PRE-BYPASS CHECKS, BUT WOULD NOT COOL DURING THE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401896 ↗MalfunctionFeb 13, 2026Insufficient Cooling
USER REPORTED THAT THE DEVICE WAS UNABLE TO MEET SETPOINT WHEN TRYING TO COOL. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24337747 ↗MalfunctionFeb 12, 2026Insufficient Cooling
USER REPORTED THE UNIT RECEIVED A TEMPERATURE FAULT WHEN ATTEMPTING TO COOL THE SYSTEMIC SIDE. THE DEVICE WOULD NOT MAINTAIN THE SET POINT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322764 ↗MalfunctionFeb 6, 2026Insufficient Cooling
USER REPORTED A FAILURE TO COOL THAT REQUIRED THE DEVICE TO BE SWAPPED DURING THE CASE. 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 24278795 ↗MalfunctionDec 18, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE HEATER-COOLER WAS UNABLE TO COOL DURING THE PROCEDURE. 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 23838488 ↗MalfunctionDec 17, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE HEATER-COOLER FAILED TO COOL DURING THE PROCEDURE. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829568 ↗MalfunctionDec 12, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid
USER REPORTED THAT IT APPEARED BLOOD HAD LEAKED FROM A HEAT EXCHANGER INTO THE HEATER-COOLER. THERE IS NO RISK OF PATIENT HARM, BUT SOME RISK OF ENVIRONMENTAL CONTAMINATION IF SITUATION IS HANDLED INCORRECTLY. THERE WAS NO HARM RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23790097 ↗MalfunctionDec 10, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE HEATER-COOLER DID NOT COOL APPROPRIATELY, WHICH IS CONSIDERED REPORTABLE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23770922 ↗MalfunctionDec 10, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE HEATER-COOLER WAS UNABLE TO COOL ON EITHER SIDE. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23770482 ↗MalfunctionDec 10, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid
USER REPORTED BLOOD LEAK FROM HEAT EXCHANGER INTO THE HEATER-COOLER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23769101 ↗MalfunctionOct 24, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE DEVICE WOULD NOT COOL DURING A CASE. THE DEVICE WAS SWAPPED FOR A BACK UP, TO COMPLETE THE CASE SUCCESSFULLY. WE CONSIDER INABILITY TO COOL TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378705 ↗MalfunctionSep 12, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE DEVICE DID NOT COOL AS EXPECTED. THERE WAS NO PATIENT HARM AS RESULT OF THE TEMPERATURE FAULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042263 ↗MalfunctionSep 10, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE DEVICE FAILED TO COOL AS EXPECTED. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018929 ↗MalfunctionAug 20, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE DEVICE DID NOT COOL THE CPG DOSE 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 22850768 ↗MalfunctionAug 20, 2025Insufficient Cooling; Insufficient Cooling
THE USER REPORTED THAT THE DEVICE DID NOT COOL EFFECTIVELY. THERE WAS NO PATIENT HARM; HOWEVER, THIS EVENT IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850767 ↗MalfunctionAug 18, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE CARDIOPLEGIA SIDE OF THE HEATER-COOLER WAS DISABLED. THE USER WAS ABLE TO REBOOT THE DEVICE AND ENABLE THE TANK; HOWEVER, FAILURE OF THE HEATER-COOLER DURING A CASE IS CONSIDERED REPORTABLE EVEN THOUGH THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22828612 ↗MalfunctionAug 8, 2025Temperature Problem; Temperature Problem
DEVICE DISPLAYED A CRITICAL HARDWARE FAILURE DURING A CASE. THERE WAS NO PATIENT HARM; HOWEVER, THE DEVICE NEEDED TO BE REPLACED DURING THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750725 ↗MalfunctionAug 8, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE DEVICE FAILED TO COOL APPROPRIATELY. THERE WAS NO PATIENT INVOLVEMENT; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750250 ↗MalfunctionAug 8, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE DEVICE FAILED TO COOL APPROPRIATELY. THE PATIENT WAS NOT INVOLVED; HOWEVER, THIS TYPE OF ISSUE IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750104 ↗MalfunctionJul 31, 2025Insufficient Cooling; Insufficient Cooling
USER REPORTED THAT THE DEVICE DID NOT OPERATE AS EXPECTED, LEADING TO THE INABILITY TO REGULATE TEMPERATURE. THERE WAS NO PATIENT HARM, BUT THE UNIT NEEDED TO BE SWAPPED DURING THE CASE TO ENSURE PATIENT SAFETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22683617 ↗
Other Controller, Temperature, Cardiopulmonary Bypass devices
- CardioQuip Modular Cooler-Heater (MCH) MCH-1000(i)Cardioquip, LLC · Controller, Temperature, Cardiopulmonary Bypass2 recalls334 reports
- Heater-Cooler System 3T 120V ~ / 60HzLivaNova Deutschland GmbH · Controller, temperature, cardiopulmonary bypass1 recall8 deaths277 reports
- CardioQuip Modular Cooler-Heater (MCH) MCH-1000(m)Cardioquip, LLC · Controller, Temperature, Cardiopulmonary Bypass2 recalls206 reports
- Hemotherm 400CEGentherm Medical, LLC · Controller, Temperature, Cardiopulmonary Bypass1 recall30 reports
- Heater-Cooler System 3T 208V ~ / 60HzLivaNova Deutschland GmbH · Controller, temperature, cardiopulmonary bypass34 reports
- MPS 3 Delivery Set w/AA w/305cm Line (16C) 5163102Quest Medical Inc · Controller, Temperature, Cardiopulmonary Bypass3 reports
- MPS 3 Delivery Set w/AA w/106cm (16C) 5163103Quest Medical Inc · Controller, Temperature, Cardiopulmonary Bypass1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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