Quantum QWSRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05060434420008), received between Jul 17, 2019 and Mar 19, 2026 — classified as 1 death, 22 malfunctions.

The most frequently reported specific device problem is “Computer Software 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Device Sensing Problem

  USER REPORTED THAT THE SAFE LEVEL FLOW CHANNEL IS ALERTING USER WHEN OPERATING IN SAFE FLOW. WHILE THERE WAS NO PATIENT HARM, THERE IS A RISK OF PATIENT HARM, SO THE EVENT IS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639796 ↗
• MalfunctionFeb 6, 2026Device Sensing Problem

  USER REPORTED THAT ALTHOUGH BUBBLE SAFETY WAS ENGAGED FROM PUMP MANAGER, THE BUBBLE DETECTION WAS ACTUALLY NOT ENGAGED. THERE WAS NO PATIENT HARM; HOWEVER, THE EVENT COULD RESULT IN PATIENT HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278782 ↗
• MalfunctionJan 22, 2026Connection Problem

  ON BYPASS INITIATION, NOT GETTING VALUES REPORTED FOR THE SAT/CRIT SENSOR. THE PROBLEM PERSISTED AFTER THE CABLE WAS REPLACED WITH THE NEW BONDED STOCK SAT/CRIT CABLE. THEY WERE ABLE TO COMPLETE CASES WITH INTERMITTENT AND ABSENT PAO2 AND HGB PRODUCING "!!!" -OR- "---." DURING TROUBLESHOOTING IT WAS IDENTIFIED THAT THE CONNECTION ON THE QWS SEEMED TO IMPROVE OR TEMPORARILY RESTORE THE SIGNAL WHEN IT WAS MANIPULATED. SUSPECTING THERE TO BE AN ISSUE WITH THE QWS DATA PORT. HAPPENED FOR CASES ON BOTH ON (B)(6). ON (B)(6): 1045-1450, ON (B)(6): 1030-1130.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143302 ↗
• MalfunctionNov 20, 2025Computer Software Problem; Unable to Obtain Readings; No Visual Prompts/Feedback; Computer Software Problem; Unable to Obtain Readings; No Visual Prompts/Feedback

  USER REPORTED THE DEVICE WAS DISPLAYING "!!!" FOR MULTIPLE VALUES. HCT/SAT SENSOR WIPED CLEAN AND VALUES FACTORY RESET, SENSOR REPLACED, HARD REBOOTS PERFORMED AND THE VALUES WERE STILL ALARMING. QWS SWAPPED TO ANOTHER HLM AND IT WORKED FOR A CASE, WITH ERRORS REAPPEARING THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603250 ↗
• MalfunctionJul 21, 2025Computer Software Problem; Pressure Problem; Computer Software Problem; Pressure Problem

  USER REPORTED THAT THE PRESSURE REGULATION FAILED ON THEIR DEVICE. THE DEVICE WAS CONTINUED TO BE USED TO COMPLETE THE CASE SUCCESSFULLY, WITH NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553219 ↗
• MalfunctionJul 17, 2025Excess Flow or Over-Infusion; Incorrect Measurement; Excess Flow or Over-Infusion; Incorrect Measurement

  THE USER REPORTED THAT THE CARDIOPLEGIA VOLUME SET, DELIVERED, AND RECORDED DIFFERED. THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533033 ↗
• MalfunctionJun 12, 2025Increase in Pressure; Increase in Pressure

  USER REPORTED THAT WHILST DELIVERING CARDIOPLEGIA IN CARDIOPLEGIA PRESSURE REGULATION MODE THEY WERE UNABLE TO REGULATE PRESSURE. USER REPORTED THAT THE PRESSURE WOULD OVERSHOOT THE TRY TO REDUCE TO ACCOMMODATE. TO RECTIFY THIS THE USER DID NOT USE REGULATION MODE. THERE WAS NO PATIENT HARM AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195238 ↗
• MalfunctionMay 21, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  USER REPORTED THAT SYSTEM OPERATED UNEXPECTEDLY BY DELIVERING VOLUME TO THE PATIENT WHEN INTENDING TO REMOVE VOLUME. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064468 ↗
• MalfunctionMay 7, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED THAT THE PUMP STOPPED DURING A 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 21979697 ↗
• MalfunctionJan 30, 2025Failure to Pump; Failure to Pump

  USER REPORTED THAT FOLLOWING AN ISSUE WITH A THIRD-PARTY PUMP, THE DECISION WAS MADE TO BRING IN A NEW HLM. HE PERFUSIONIST TRANSFERRED THE RECORD. ON THE NEW QUANTUM HLM THE CASE WAS RECOVERED BUT ALL OF THE PUMPS WERE MISLABELLED AND WOULD NOT OPERATE. THE PERFUSIONIST BEGAN HAND CRANKING WHILE THE ISSUE WAS SORTED OUT BY ANOTHER PERFUSIONIST. INTERRUPTION TO BLOOD FLOW IS CONSIDERED A REPORTABLE EVENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273570 ↗
• MalfunctionJan 30, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IMPOSSIBLE TO ACTIVATE SWEEP WHILE GOING ON BYPASS. SWEEP FLOW REMAINED 'BLINKING' ON QVM. NO INFORMATION RECEIVED IF QWS PATIENT MANAGER WAS USED AS WELL OR NOT. PERFUSIONIST PANICKED AND WEANED BACK FROM BYPASS, HAS CHANGED THE WHOLE QUANTUM CONSOLE FOR A BACKUP S5 AND FINISHED PROCEDURE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272235 ↗
• MalfunctionJan 30, 2025Improper Flow or Infusion; Improper Flow or Infusion

  WHILE USING PCO2 AUTO-REGULATION THIS MORNING, PCO2 WAS UNABLE TO MAINTAIN SET POINT. PCO2 WAS SET AT 40 AND THE SWEEP STARTED AT 2LPM. OVER 15 MINS THE SWEEP WENT TO .5 LPM AND THE PCO2 WAS READING 29. WHEN THE CLINICIAN TRIED AGAIN LATER IN THE CASE AND IT WORKED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272166 ↗
• MalfunctionDec 2, 2024Improper Flow or Infusion; Improper Flow or Infusion

  PERUSIONSIT REPORTED RETROGRADE FLOW DURING A CASE. HE FINISHED THE CASE SUCCESSFULLY BY SWITCHING TO A HAND CRANK. WE CONSIDER INABILITY TO REGULATE PRESSURE TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817282 ↗
• MalfunctionNov 18, 2024Unexpected Shutdown; Unexpected Shutdown

  PERFUSIONIST REPORTED UNEXPECTED SHUTDOWN OF DEVICE BEFORE CASE. THE PERFUSIONIST WAS ABLE TO TURN THE SYSTEM ON AND COMPLETE THE CASE AS NORMAL. WE CONSIDER THE BLOOD FLOW BEING INTERRUPTED DUE TO A SYSTEM SHUTDOWN TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20707890 ↗
• MalfunctionSep 27, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  WHILE ON BYPASS, MICROSOFT ALERT POPPED UP ON VIPER INTRA-OP TAB READING "G3SHELL MAIN APPLICATION HAS STOPPED WORKING. A PROBLEM CAUSED THE PROGRAM TO STOP WORKING CORRECTLY. PLEASE CLOSE THE PROGRAM". VIPER APPLICATION CRASHED. PERFUSIONIST ABLE TO START RECORD AND READ PREVIOUS RECORD FILE. UPON VIPER STARTING UP AGAIN, CARDIOPLEGIA PUMPS TURNED OFF MID-DOSE (WAS RUNNING AT 0.14 LPM AND RATIO OF 1:0) AND RESET RATIO TO 8:1. VIPER AND OTHER PUMPS CONTINUING TO OPERATE AS NORMAL AFTER STARTING AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320324 ↗
• MalfunctionJul 5, 2024Increased Pump Speed; Increased Pump Speed

  CUSTOMER REPORTED AN EVENT WHERE THE FOLLOWING TOOK PLACE DURING A CARDIOPULMONARY BYPASS PROCEDURE: 1. HIGH PRESSURE EVENT STOPPED CARDIOPLEGIA PUMP. 2. AFTER PRESSURE RELIEF, PUMP STARTED WITH HIGH RPM INSTEAD OF SLOWLY REGULATING -> FREQUENCY OF OCCURRENCE 2-3 TIMES. NO CONSEQUENCES TO PATIENT (I.E., NO HARM) AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19679521 ↗
• MalfunctionJul 5, 2024Pumping Stopped; Pumping Stopped

  ARTERIAL PUMP STOPPED SUDDENLY 32 MINUTES AFTER THE BEGINNING OF THE CASE. "!!!" SIGNAL WAS DISPLAYED UNDER THE ARTERIAL PRESSURE. THE ALARM OF ARTERIAL PRESSURE WHICH CONTROLS THE ARTERIAL PUMP WAS DISABLED BUT THE ARTERIAL PUMP DIDN'T RESTART. THE PERFUSIONIST CHANGED OUT THE ARTERIAL PRESSURE SENOR: THE PUMP STILL DID NOT RESTART. THE USER REPORTED THAT THE PUMP STOPPED AND STARTED FOR PERIOD OF TIME. FINALLY, THE PERFUSIONIST CHANGED OUT THE ARTERIAL PRESSURE SENSOR AND PRESSURE CABLE, AT THIS POINT THE ARTERIAL PUMP RESTARTED, THE REST OF THE CASE WAS PERFORMED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19679445 ↗
• DeathFeb 6, 2024Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  THERE WAS AN EVENT AT (B)(6) HOSPITAL CENTER WHERE A PATIENT EXPIRED WHILE ON CPB. THE CASE WAS AN AORTIC DISSECTION. THEY WERE FLOWING BETWEEN 5-6 LPM ON QUANTUM PERFUSION CP37 AND THE CROSS CLAMP WAS OFF. THEN, THE PERFUSIONIST NOTED THAT HE COULD NOT GET ANY FLOW AND HIS RPMS WOULD NOT GET ANY GREATER THAN 700. AFTER THE PERFUSIONIST FAILED TO INCREASE RPMS, HE THEN TRIED TO HAND CRANK BUT COULD NOT ESTABLISH FLOW WITH THE HAND CRANK EITHER. THE PATIENT EXPIRED A FEW MINUTES LATER. AFTER THE PATIENT EXPIRED THEY NOTICED AN "ERROR MESSAGE" ON THE LEVEL TAB OF THE ARTERIAL PUMP TILE. AFTER THE CASE, THEY CLOSED THE CIRCUIT LOOP AND WERE ABLE TO HAND CRANK WITHOUT AN ISSUE.

  Patient problems: Reduced Blood Flow

  MAUDE report 18648997 ↗
• MalfunctionOct 19, 2021Positioning Failure; Positioning Failure

  AIR PULLED INTO CPB CIRCUIT FROM CARDIOPLEGIA PUMP DURING A CASE AT APPROXIMATELY 1712 IN OPERATING ROOM 3 AT (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 12656977 ↗
• MalfunctionOct 19, 2021Infusion or Flow Problem; Air/Gas in Device

  THE INCIDENT OCCURRED ABOUT 5 MINUTES AFTER THE ESTABLISHMENT OF CPB. PATIENT WAS ON CPB FOR THE REPAIR OF AN EMERGENCY AORTIC DISSECTION. AS THE ASCENDING AORTA WAS TO BE REPLACED/REPAIRED THE CPB CIRCUIT CONSISTED OF ONE FOR THE SYSTEMIC CIRCULATION AND ONE FOR THE CEREBRAL CIRCULATION. THE CEREBRAL CIRCULATION INLET BRANCHED OFF THE ARTERIAL LINE OF THE CPB CIRCUIT. THE CEREBRAL CIRCUIT WAS FLOWING AT JUST OVER A ONE LITRE PER MINUTE. SURGEON ASKED FOR PATIENT TO BE FILLED, OCCLUDING THE VENOUS LINE FILLED THE PATIENT AND DECREASED THE VOLUME IN THE RESERVOIR, THE RESERVOIR VOLUME DROPPED TRIGGERING THE SAFE FLOW SENSOR. THE TRIGGERING OF THE SAFE FLOW SENSOR DROPS THE ARTERIAL PUMP TO EQUAL WHAT IS FLOWING THROUGH THE VENOUS LINE, IN THIS INSTANCE THE CEREBRAL FLOW WAS GREATER THAN THE ARTERIAL FLOW AND THEREFORE, AIR WAS DRAGGED ACROSS THE OXYGENATOR MEMBRANE. THE PERFUSIONISTS HAD INTERLOCKED THE CEREBRAL PUMP TO THE ARTERIAL PUMP AND ASSUMED THAT AS THE ARTERIAL PUMP FLOWS DROPPED SO WOULD THE CEREBRAL PUMP FLOWS. THE PERFUSIONISTS AT THE TIME NOTED THAT AIR HAD BEEN DRAGGED ACROSS THE MEMBRANE AND THAT IT HAD ENTERED THE CEREBRAL CIRCUIT. SURGEON ALSO NOTICED THE AIR IN THE

  Patient problems: Insufficient Information

  MAUDE report 12656817 ↗
• MalfunctionOct 19, 2021Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  THE CLINICIAN REPORTED THAT A PATIENT WAS ON CPB, AND NOTED THAT HIGH LINE PRESSURE WAS CREATED FROM KINK IN THE ARTERIAL LINE, MAX PRESSURE WAS INCREASED, HIGH LINE PRESSURE CREATED AGAIN WITH A KINK IN THE ARTERIAL LINE, MAX PRESSURE SERVO REGULATED THE PUMP TO NO FLOW, INTERLOCKED CARDIOPLEGIA PUMP STILL RUNNING, CREATED NEGATIVE PRESSURE IN THE ARTERIAL CIRCUIT, AIR WAS SEEN IN THE OXYGENATOR AND THE ARTERIAL BUBBLE DETECTOR SHUT OFF ARTERIAL PUMPS AND DEPENDENT PUMPS. PATIENT WAS OFF CPB FOR 4 MINUTES WHILE THEY DEAIRED THE SYSTEM. WENT BACK ON CPB AND FINISHED THE CASE. THE SYSTEM BEHAVED AS EXPECTED. THE SOFTWARE LOGS REVEALED RECOMMENDED STEPS WERE NOT FOLLOWED.

  Patient problems: Insufficient Information

  MAUDE report 12656643 ↗
• MalfunctionJul 17, 2019Computer Software Problem; Computer Software Problem

  SPECTRUM MEDICAL LTD RECEIVED AN INCIDENT REPORT ON 24TH MAY 2019 THAT THE QUANTUM PUMP CONSOLE SHUT DOWN ON (B)(6) 2019 DURING TETRALOGY OF FALLOT OPEN HEART SURGERY. HAND CRANK OF THE PUMP WAS USED TO MAINTAIN PATIENT SUPPORT, OPERATION COMPLETED SUCCESSFULLY. NO INJURY TO THE PATIENT. THE PERFUSION SYSTEM IDENTIFIER FROM (B)(6) FOR THIS PARTICULAR HLM WAS IDENTIFIED VIA THE SYSTEM MONITOR, QWS (B)(4). SUMMARY OF THE ASSESSMENT: THE SOFTWARE TEAM REVIEWED THE INCIDENT REPORT AND THE DIAGNOSTIC LOGS AND HAVE IDENTIFIED THAT INCORRECT DATA WAS QUERIED FROM THE BATTERY FIRMWARE LEADING TO POWER LOSS TO THE ACCESSORY PORTS ON THE HLM. IT WAS DETERMINED THAT THE CORRECTIVE ACTION IS A SOFTWARE UPDATE THAT WILL FIX THE VULNERABILITY THAT CREATED THIS MALFUNCTION OF THE POWER SUPPLY. THIS SAME ISSUE WAS IDENTIFIED IN MDR-001 REPORT. A FIELD SAFETY CORRECTION WILL BE ISSUED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8797026 ↗
• MalfunctionJul 17, 2019Computer Software Problem; Computer Software Problem

  SPECTRUM MEDICAL RECEIVED A REPORTED INCIDENT ON (B)(6) 2019. THIS INVOLVED THE QUANTUM PUMP CONSOLE SYSTEM SHUTTING DOWN WHEN PREPARING TO WEAN PATIENT OFF BYPASS. THE PERFUSION SYSTEM IDENTIFIER FROM (B)(6) FOR THIS PARTICULAR HLM IS HLM-04, IDENTIFIED VIA THE SYSTEM MONITOR, QWS (B)(4), AND THE POWER SUPPLY, QPS (B)(4). THE INCIDENT REPORT AND THE DIAGNOSTIC LOGS AND HAVE IDENTIFIED THAT INCORRECT DATA WAS QUERIED FROM THE BATTERY FIRMWARE LEADING TO POWER LOSS TO THE ACCESSORY PORTS ON THE HLM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8797017 ↗