Quantum QWS12ERecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05060434422309), received between Apr 4, 2024 and Jun 15, 2026 — classified as 2 deaths, 25 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (9 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Failure to Pump

  USER REPORTED THAT AFTER BEING AT ZERO FLOW STATE, THERE WAS DIFFICULTY RE-ESTABLISHING FLOW. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504027 ↗
• MalfunctionJun 4, 2026Infusion or Flow Problem

  USER REPORTED THAT THEY WERE UNCLEAR WHETHER THERE WAS POSITIVE FLOW AFTER HARD REBOOT, SO THE USER RESORTED TO HAND-CRANKING UNTIL CERTAIN THAT THERE WAS FLOW. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25396168 ↗
• MalfunctionMay 20, 2026Pumping Stopped

  USER REPORTED THAT THE WHILE THE SYSTEM WAS SUPPORTING A PATIENT, THE SYSTEM WAS UNPLUGGED TO MOVE THE PATIENT AND THE PUMP DID NOT CONTINUE. THE USER HAD TO HAND-CRANK. THE UNIT WAS TURNED BACK ON WITH THE POWER BUTTON AND CONTINUED TO OPERATE AS EXPECTED AFTER. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228881 ↗
• MalfunctionMar 13, 2026Pumping Stopped

  USER REPORTED THAT THE WORKSTATION GLITCHED MOMENTARILY AND BLOOD FLOW WAS TEMPORARILY INTERRUPTED, WHICH IS CONSIDERED A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590107 ↗
• MalfunctionMar 5, 2026Pumping Stopped

  USER REPORTED THAT SENSOR MEASUREMENTS WERE BLANK, WHICH LED THE USER TO REPLACE DEVICES IN THE CIRCUIT, ULTIMATELY RESULTING IN THE PUMP TEMPORARILY STOPPING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520213 ↗
• MalfunctionDec 22, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED INABILITY TO FLOW TO PATIENT AND HAD TO RESORT TO HAND-CRANKING DUE TO SYSTEM ALARMS. THIS TYPE OF EVENT IS CONSIDERED REPORTABLE ALTHOUGH THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865090 ↗
• MalfunctionDec 10, 2025Pumping Stopped; Pumping Stopped

  USER IGNORED BATTERY WARNINGS, WHICH RESULTED IN A CRITICAL SYSTEM SHUTDOWN, CAUSING THE PUMP TO STOP. THERE WAS NO PATIENT HARM AS THE USER RESORTED TO HAND-CRANKING; HOWEVER, A PUMP STOP IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769149 ↗
• MalfunctionOct 15, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  USER REPORTED THAT A SCREEN RESET CAUSED THE RPMS TO RETURN TO 0RPM AND THE USER HAD TO MANNUALLY INCREASE RPMS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297783 ↗
• MalfunctionOct 15, 2025Pumping Problem; Pumping Problem

  USER REPORTED ISSUES WITH LOGGING IN TO CLEAR ALARMS, WHICH CAUSED THE PATIENT TO BE OFF SUPPORT FOR A SHORT PERIOD OF TIME. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297714 ↗
• MalfunctionAug 27, 2025Gas Output Problem; Gas Output Problem

  USER REPORTED THAT THE SWEEP FELL TO ZERO REGARDLESS OF THE SETPOINT. ALTHOUGH THERE WAS NO PATIENT HARM, THIS EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905898 ↗
• MalfunctionJul 24, 2025Failure to Pump; Failure to Pump

  USER REPORTED THAT A PUMP ERROR OCCURRED CAUSING PUMP TO BE INOPERABLE IN THE CIRCUIT. ADDITIONAL CLINICAL INTERVENTION WAS REQUIRED TO EXCHANGE THE CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588014 ↗
• DeathJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT OCCURRED THAT RESULTED IN PATIENT DEATH WHILE PATIENT WAS CONNECTED TO THE MEDICAL DEVICE. USER REPORTED THAT BLOOD FLOW WAS UNABLE TO BE RE-ESTABLISHED FOLLOWING CPR AND PATIENT EXPERIENCED HEMORRHAGE BENEATH THE HEART. THE INVESTIGATION DETERMINED THAT THE DEVICE DID NOT MALFUNCTION DURING USE AND WAS OPERATING AS INTENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22564806 ↗
• MalfunctionJul 2, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED THAT THE SYSTEM ALARMED AND STOPPED FLOW, BUT THE REASON WAS UNKNOWN. THE USER RESORTED TO HAND-CRANKING AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382347 ↗
• MalfunctionJun 19, 2025Device Emits Odor; Device Emits Odor

  USER REPORTED A BURNING SMELL FROM THE DEVICE. THERE WAS NO PATIENT OR OPERATOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289847 ↗
• MalfunctionMay 7, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED PUMP STOP WHEN INTERACTING WITH POP-UP MESSAGES. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS A PUMP STOP TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979609 ↗
• MalfunctionMay 7, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED SYSTEM SCREENS WENT BLANK AND PUMP STOPPED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979600 ↗
• MalfunctionJan 31, 2025Pumping Stopped; Pumping Stopped

  USER REPORTED TWO OCCASIONS OF PUMP STOPPAGE DURING A CASE. FOR THE DEVICE (SERIAL NUMBER: (B)(6), IT WAS REPORTED THAT THE PUMP RPM DECREASED TO 0 WHEN ZEROING THE PIN SENSOR. FOR THE DEVICE (SERIAL NUMBER: (B)(6), IT WAS REPORTED THAT THE BLOOD FLOW STOPPED WHEN REPOSITIONING A SENSOR. IN BOTH CASES THE OPERATION WAS CONTINUED WITH THE DEVICES AND COMPLETED SUCCESFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282616 ↗
• MalfunctionDec 6, 2024Failure to Sense; Failure to Sense

  PERFUSIONIST REPORTED THAT THE DEVICE DID NOT ALARM, DESPITE AIR BEING VISIBLE WITHIN THE SYSTEM, WE CONSIDER FAILURE TO DETECT GROSS EMBOLI TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862281 ↗
• MalfunctionDec 2, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  PERFUSIONIST REPORTED THAT THE SCREEN FROZE DURING A CASE, WHICH LED TO THE PUMP SPEED ACCIDENTALLY BEING ADJUSTED TO 6000 RPM. THIS WAS ABLE TO BE RECTIFIED IMMEDIATELY AND THE CASE COMPLETED SUCCESSFULLY. WE CONDER INABILITY TO CONTROL THE PUMP TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817090 ↗
• MalfunctionNov 26, 2024Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  PERFUSIONIST REPORTED THAT THE ELITE TOUCH SCREEN FROZE DURING A CASE. THEY WERE UNABLE TO CONTROL THE PUMP, SO THEY REPLACED IT WITH THE BACK UP TO SUCCESSFULLY COMPLETE THE CASE. LOSS OF ABILITY TO CONTROL PUMP CONSIDERED A REPORTABLE EVENT, DESPITE NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784271 ↗
• MalfunctionNov 4, 2024Misconnection; Misconnection

  PERFUSIONIST REPORTED THAT THEY WERE UNABLE TO ADJUST RPM OR TURN ON BUBBLE SENSOR OF THE CENTRIFUGAL PUMP, WHEN USING THE TOUCH SCREEN. THE ISSUE SPONTANEOUSLY RESOLVED ITSELF ON THE FIRST OCCURRENCE. WE DEEM INABILITY TO CONTROL THE PUMP A REPORTABLE OCCURRENCE. PERFUSIONIST SUBSEQUENTLY REPORTED THAT THE BUBBLE ALARM WOULD NOT SOUND WHEN TESTED UNDER EXPECTED ALARM CONDITIONS. WE DEEM FAILURE TO DETECT GROSS EMBOLI A REPORTABLE OCCURENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599820 ↗
• DeathNov 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WAS PLACED ON ECMO ON THE SEPTEMBER 30TH, AT APPROX 2:15 AM, AND TRANSPORTED TO CTICU WHERE THE EQUIPMENT WAS PLUGGED INTO THE WALL OUTLET AND GAS LINES WERE HOOKED UP TO THE WALL GAS SOURCE. AT THIS POINT EVERYTHING WAS OPERATING CORRECTLY, AND THE PATIENT SEEMED RELATIVELY STABLE WHILST RECEIVING BLOOD FOR A CONCERN OF POSSIBLE VOLUME LOSS. AT 5:03 AM THE PERFUSIONIST RECEIVED A PHONE CALL FROM A NURSE WHO SAID THAT THE PATIENT WAS TO HAVE THEIR CHEST OPENED AT BEDSIDE AND THAT A CELL SAVER WAS REQUIRED. THEY ALSO SAID THAT THE PUMP WAS OFF AND THEY ESTABLISHED THAT THE WORKSTATION AND THE VENTILATION MODULE WERE ALSO OFF. THE BLOOD IN THE CIRCUIT APPEARED DARK. THE NURSE WAS UNABLE TO DETERMINE HOW LONG THE SYSTEM HAD BEEN OFF FOR AT THAT POINT. SHE PROCEEDED TO CONNECT THE GAS LINE DIRECTLY TO THE O2 TANK AND SET THE SWEEP TO 1 L/MIN. WHEN THE PERFUSIONIST JOINED THEM, THE EMERGENCY HAD BEGUN AND THE SWEEP CONTINUED TO BE SET AT 1 L/MIN, THE PERFUSIONIST CHANGED IT TO THE PREVIOUS SETTING OF 3 L/MIN AND TRIED TO RECOVER THE OLD CASE. THE PERFUSIONIST POWERED THE WORKSTATION AND THE VENTILATION MODULE OFF AND REBOOTED, AFTER WHICH THEY WERE ABLE TO FIND THE PROPER CASE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20598596 ↗
• MalfunctionOct 21, 2024Incorrect Measurement; Incorrect Measurement

  THE CUSTOMERS REPORTED THE SAO2 READING WAS LOW (73%) ON THE SYSTEM VS. LAB VALUE. THEY TRIED TO CAPTURE/SYNC THE VALUE UP TO 100% BUT WAS UNSUCCESSFUL. FACTORY RESET WAS DONE SEVERAL TIMES, REGULAR REBOOT AND HARD REBOOT BOTH DONE. SAO2 READING REMAINED LOW. THE SAME SAT/HCT SENSOR WAS MOVED ONTO A M4 MONITOR AND THE SAO2 IS READING 100%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493746 ↗
• MalfunctionSep 27, 2024Use of Device Problem; Use of Device Problem

  AN ECMO COORDINATOR FROM UCSD MEDICAL CENTER SENT AN EMAIL REPORTING AN INCIDENT WITH A QUANTUM ELITE GOING TO ZERO RPM WITHOUT ANYONE MAKING ANY CHANGES TO THE PATIENT OR THE MACHINE. THERE WAS A LOW FLOW ALARM THAT WAS HEARD BY THE BEDSIDE ECMO SPECIALIST AND WHEN HE WENT INSIDE THE PATIENT ROOM, THE ELITE WAS FOUND AT ZERO RPM. THE PATIENT SATURATIONS DROPPED FROM 99% TO 94% BRIEFLY BUT OTHER THAN THAT PATIENT WAS STABLE, NO ISSUES, AND WAS BEING WEANED OFF SUPPORT TOWARDS DECANNULATION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20319890 ↗
• MalfunctionAug 9, 2024Computer Software Problem; Computer Software Problem

  EVENTS OCCURRED DURING THE 1500 HOUR AS FOLLOWS: 1. ECMO SPECIALIST NOTICED NEGATIVE ART FLOW IN PARALLEL WITH ECMO PRIMER NOTICING BACKWARD FLOW 2. PATIENT CLAMPED OFF IMMEDIATELY - HAND CRANKING RESUMED 3. CLINICIANS STARTED TROUBLESTHOOTING A. RESET QWS - TRIED GETTING SWEEP GAS TO CONNECT TO TANKS BUT WAS RUNNING SHORT ON TUBING, SO DID NOT DO A HARD RESET FROM THE BOTTOM OF THE FRAME B. WENT INTO ADMIN MODE TO ENSURE THEY HAD COUNTERCLOCKWISE SELECTED, SWAPPED TO CLOCKWISE, UNCLAMPED, NO CHANGE. WENT BACK TO COUNTERCLOCKWISE, NO CHANGE. C. SWAPPED OUT ROLLER PUMP UNIT WHILE REMAINING ON SAME FRAME/QWS/QVM D. REGAINED FORWARD COUNTERCLOCKWISE FLOW 4. RED HERRING - THIS WAS IMMEDIATELY AFTER A RACEWAY WALK AND PRIOR TO STARTING, SPECIALIST TURNED DOWN FLOW TO "OFF", THERE WAS STILL A WHIFF GOING THROUGH SO PRIMER TAPPED THE STOP BUTTON (PRIOR TO LIFTING LID), SCREEN NOTIFICATION POPPED UP AND SPECIALIST QUICKLY TAPPED YES. THE CLINICIANS TROUBLESHOT TOGETHER AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19948748 ↗