Quantum QWS15SRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05060434422293), received between Aug 23, 2021 and Jun 19, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Decreased Pump Speed” (2 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Decreased Pump Speed

  THE USER REPORTED A SUDDEN DECREASE FROM FULL FLOW TO 0.5 LPM WITHOUT APPARENT REASON. THE USER RESUMED ADEQUATE FLOW AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25560983 ↗
• MalfunctionMay 8, 2026Unintended Application Program Shut Down

  QWS HAD UNEXPECTED SHUT-DOWN MID-CASE. POWER BUTTON DID NOT APPEAR TO HAVE BEEN PRESSED FOR 10 SECONDS BY USER OR PUSHING AGAINST OTHER EQUIPMENT. QWS BOOTED BACK UP INDEPENDENTLY WITH SPECTRUM LOGO ROTATED 45 DEGREES AND "SYSTEM ERROR" MESSAGE DISPLAYED ON THE SCREEN. QWS SHUT ITSELF OFF AGAIN AND BOOTED BACK UP PROPERLY IMMEDIATELY AFTER. USER WAS STILL ON BYPASS AND DID NOT ATTEMPT A HARD REBOOT OF THE QWS OR A SWAP TO A NEW QWS. ALL TIMERS, RECORD, ETC. WERE LOST UPON QWS START UP BUT NO OTHER EFFECTS TO OPERATIONS OF THE REST OF THE HLM. AFTER THE CASE LOGS WERE PULLED AND NO REPORTS OF FAILURE SINCE THEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123020 ↗
• MalfunctionMar 30, 2026Backflow

  USER REPORTED INACCURATE DELIVERY OF VOLUME. THERE WAS NO PATIENT HARM; HOWEVER, UNRELIABLE VOLUME DELIVERY IS CONSIDERED A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728019 ↗
• MalfunctionMar 18, 2026Pumping Problem

  USER REPORTED BOTH LACK OF RESPONSE FROM LEVEL DECREASING BELOW SAFE LEVEL AND RPMS NOT REACHING THE INTENDED SPEED. BOTH COULD BE CONSIDERED A RISK TO THE PATIENT IF THEY WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626505 ↗
• MalfunctionFeb 27, 2026Application Program Freezes or Fails to Launch

  DURING REDUCTION OF CPB FLOW TO 1.0 LPM FOR CROSS-CLAMP REMOVAL, THE TOUCHSCREEN FAILED TO RESPOND WHILE DEACTIVATING THE CROSS-CLAMP TIMER. INITIATION MODE WAS INADVERTENTLY ACTIVATED. THE ARTERIAL FLOW CONTROL DIAL DISPLAY SWITCHED TO "VENOUS OCCLUDER," AND ARTERIAL FLOW REMAINED BELOW 1.0 LPM WITH THE CLAMP BEING OPEN. ATTEMPTS TO DEACTIVATE "INITIATION MODE" WERE UNSUCCESSFUL. THE CIRCUIT WAS MANUALLY CLAMPED, THE SURGICAL TEAM WAS NOTIFIED, AND THE CP37 PUMP HEAD WAS PLACED ON EMERGENCY HAND-CRANK TO RESTORE FLOW AND MAP. IN A FINAL ATTEMPT, INITIATION MODE WAS DEACTIVATED SUCCESSFULLY, THE PUMP RETURNED TO EXTERNAL DRIVE, AND THE PATIENT WAS SUCCESSFULLY WEANED FROM CPB. THE QWS WAS INSPECTED AFTER THE CASE, BUT THE SPECIFIC SOFTWARE/TOUCHSCREEN GLITCH COULD NOT BE REPRODUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468074 ↗
• MalfunctionFeb 20, 2026Decreased Pump Speed

  USER REPORTED THAT THE PROTECTED LEVEL FLOW WAS INCORRECTLY TRIGGERED MULTIPLE TIMES 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 24401565 ↗
• MalfunctionJan 23, 2026Output Problem

  CUSTOMER IN BERN CONTACTED US THAT THE INLET PRESSURE FOR THE CARDIOPLEGIA TRIGGERS AT 10 MMHG WHILE IT IS SET TO 0 MMHG. THE SETTINGS HAVE BEEN CHECKED BY AN ENGINEER AND CONFIRMED THAT IT TRIGGERS AT 10 MMHG AND NOT THE SET 0 MMHG. THE ISSUE DOESNT HAVE ANY CLINICAL IMPLICATION BECAUSE 10 MMHG IS LOW ENOUGH TO KEEP CARDIOPLEGIA FUNCTIONAL DURING CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159409 ↗
• MalfunctionDec 3, 2025Pumping Problem; Pumping Problem

  USER REPORTED THAT THE ARTERIAL OCCLUDER WOULD NOT FULLY CLOSE AND THEY HAD TO USE A CLAMP. 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 23703733 ↗
• MalfunctionNov 12, 2025Failure to Pump; Failure to Pump

  USER REPORTED THAT THE CARDIOPLEGIA PUMP FAILED WHEN ATTEMPTING TO GIVE CARDIOPLEGIA. WHILE THERE WAS NO PATIENT HARM, THIS IS CONSIDERED REPORTABLE AS PROVIDING CARDIOPLEGIA IS CRITICAL FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533246 ↗
• 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 22904941 ↗
• MalfunctionMay 15, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  USER REPORTED ROUTE AND TYPE OF CARDIOPLEGIA DELIVERED DURING THE CASE WERE BEING ALTERED IN THE PATIENT CHART WITHOUT PROMPTING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026987 ↗
• MalfunctionMay 2, 2025Premature Activation; Premature Activation

  USER REPORTED EVENT OF UNINTENTIONAL CLOSING OF ARTERIAL OCCLUDER DUE TO DYNAMIC POPUP WINDOW ON THE DISPLAY. WHILE ENTERING DATA ON TO THE QUANTUM WORKSTATION, THE USER REACHED THE PROTECTED LEVEL, RESULTING IN THE DYNAMIC DISPLAY POPPING UP. THE POP UP APPEARED EXACTLY AT THE PLACE OF THE MANUAL ENTRY, THE ICON FOR CLOSE ART CLAMP WAS LOCATED, RESULTING IN THE USER PRESSING FOR A CLOSED ART CLAMP AND INTURRUPTING THE BLOOD FLOW. THE USER WAS ABLE TO DISABLE THE OCCLUDER AND CONTINUE THE CASE WITHOUT ISSUE. THERE WAS NO PATIENT HARM AS A RESULT OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949852 ↗
• MalfunctionApr 11, 2025Human-Device Interface Problem; Human-Device Interface Problem

  USER REPORTED THAT THE QUANTUM WORKSTATION TOUCH SCREEN FAILED TO RESPOND DURING A CASE. USER NOTED POP-UP OF CARDIOPLEGIA PUMP TILE MENU AND COULD NOT EXIT THE POP UP OR CLICK ANYWHERE ELSE ON THE SCREEN WITH RESPONSE. QUANTUM WORKSTATION WAS IMMEDIATELY REPLACED WITH BACK UP FROM OTHER HLM SO PATIENT COULD BE SAFELY SUPPORTED INITIATING BYPASS. QUANTUM WORKSTATION WAS HARD REBOOTED OUTSIDE OF THE OR AND ABILITY TO TOUCHSCREEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21824954 ↗
• MalfunctionDec 2, 2024Increased Pump Speed; Increased Pump Speed

  USER REPORTED AN UNEXPECTED PUMP SPEED INCREASE TO 6000 RPM. THE USER REPORTED THAT THE ISSUE "FIXED ITSELF" A MINUTE AFTER. WE CONSIDER UNEXPECTED PUMP INCREASE A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818960 ↗
• MalfunctionNov 5, 2024Pumping Stopped; Improper or Incorrect Procedure or Method; Pumping Stopped; Improper or Incorrect Procedure or Method

  PERFUSIONIST REPORTED THAT SEVERAL ALARMS SOUNDED, AND EXPERIENCED A PUMP STOP DURING A CASE. THEY WERE UNABLE TO DIAGNOSE REASON FOR BOTH, LEADING TO THE PERFUSIONIST SWITCHING TO USE A HAND CRANK AS A PRECAUTIONARY MEASURE AND SWITCHING PUMP OUT - AFTER OBSERVING RETROGRADE FLOW. WE CONSIDER A PUMP STOP TO BE REPORTABLE; HOWEVER, THE PATIENT WAS INVOLVED WITHOUT ANY CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20607842 ↗
• MalfunctionAug 23, 2021Mechanical Problem; Infusion or Flow Problem

  CLINICIAN REPORTS THAT CIRCUIT BEGAN LOSING VENOUS FLOW CAUSING SAFE FLOW TO ENGAGE. CLINICIAN DOES NOT HAVE A VENOUS FLOW PROBE ON HIS CIRCUIT SO ARTERIAL FLOW DROPPED TO 25% OF LAST KNOW FLOW. CLINICIAN NOTES SEEING ARTERIAL PUMP SLOW. CLINICIAN ALSO STATES THAT INTERLOCKED UF PUMP CONTINUED TO SPIN AT SAME RATE DESPITE ARTERIAL PUMP SLOWING. CLINICIAN THEN STATES THAT PROTECTED FLOW LEVEL WAS HIT AND ARTERIAL PUMP STOPPED. CLINICIAN STATES THAT INTERLOCKED UF CONTINUED TO SPIN. CLINICIAN STATES THAT AIR WAS ENTRAINED IN THE MEMBRANE. PATIENT CAME OFF BYPASS FOR APPROXIMATELY 1 MINUTE TO DE-AIR MEMBRANE. PATIENT WAS HYPOTENSIVE DURING AND AFTER EVENT BUT WAS OTHERWISE STABLE.

  Patient problems: Low Cardiac Output

  MAUDE report 12353161 ↗