Quantum QSOR (REF 51-000074-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05060434423443), received between Nov 27, 2024 and Jan 9, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Infusion or Flow Problem

  USER REPORTED THAT THE OCCLUDER WOULD NOT FUNCTION DURING THE PROCEDURE. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019721 ↗
• MalfunctionNov 18, 2025Infusion or Flow Problem; Infusion or Flow Problem

  DURING A CARDIOPULMONARY BYPASS (CPB), AN ISSUE OCCURRED WITH THE VENOUS OCCLUDER ON CONSOLE PH1004201. WHILE ATTEMPTING TO FILL THE HEART AT THE SURGEON'S REQUEST, THE OPERATOR GRADUALLY CLOSED THE VENOUS OCCLUDER. AT THE MOMENT OF TRYING TO STABILIZE THE LEVEL, THE RESERVOIR SUDDENLY EMPTIED COMPLETELY, AND THE LEVEL SENSOR WAS TRIGGERED, PREVENTING FURTHER MANUAL CONTROL. IT WAS THEN DISCOVERED THAT THE VENOUS OCCLUDER WAS FULLY CLOSED, DESPITE THE SCREEN INDICATING OTHERWISE. ATTEMPTS TO REOPEN IT USING THE "CLAMP OPEN 100%" AND "CLAMP RELEASE" BUTTONS WERE UNSUCCESSFUL. THE OPERATOR HAD TO UNPLUG AND RECONNECT THE OCCLUDER, AFTER WHICH IT RESTARTED AND CONTROL OF THE CPB WAS REGAINED. ADDITIONAL INFORMATION: - THE CARRIAGE TEST HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE PROCEDURE. - THE OCCLUDER'S BLUE LED WAS STEADY DURING THE INCIDENT. - THE PATIENT WAS IN THE COOLING PHASE, SO NO CLINICAL CONSEQUENCES RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581844 ↗
• MalfunctionJul 31, 2025Failure to Advance; Failure to Advance

  USER REPORTED THAT DURING THE CASE THE PUMP AND OCCLUDER WERE WORKING WITHOUT ISSUE. THE USER SET THE DEMAND FOR THE PUMP DOWN TO ZERO AND THE OCCLUDER CLAMPS CLOSED AS EXPECTED. AT THE END OF THE CASE (WHILE IN WEANING MODE) THE USER TRIED TO CONTINUE TRANSFUSING BUT THE PUMP DID NOT TURN AND THE OCCLUDER CAMPS REMAINED CLOSED. THIS WAS NOT EXPECTED. THE USER EXITED WEANING MODE AND AND PROCEEDED TO TRANSFUSE MANUALLY. THERE WAS NO PATIENT HARM AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675222 ↗
• MalfunctionApr 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER REPORTED THAT PRESET BUTTON FOR VOLUME REMOVAL RESULTED IN AN INCORRECT ACTION, CAUSING VOLUME TO BE DELIVERED TO THE PATIENT INSTEAD. THE USER WAS ABLE TO UTILIZE ANOTHER FEATURE OF THE SYSTEM TO RESOLVE THE ISSUE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910609 ↗
• MalfunctionJan 31, 2025Mechanical Problem; Pumping Problem; Mechanical Problem; Pumping Problem

  THE PERFUSIONIST WAS IN WEANING MODE BUT HAD TO GO BACK ON BYPASS (HE WAS NOT COMPLETELY OFF YET AND HAD SOME FLOW). HE TRIED INCREASING THE FLOW USING THE VENOUS OCCLUDER BUT THE FLOW DID NOT GO UP. HE GOT OUT OF THE WEANING MODE AND SELECTED THE "OPEN" ICON IN THE VENOUS TILE BUT THE OCCLUDER REMAINED IN THE SAME POSITION. HE TRIED USING THE RELEASE BUTTON IN THE VENOUS TILE BUT THE OCCLUDER BOBBINS STILL DID NOT MOVE. HE PHYSICALLY TOOK OUT THE BOBBINS FROM THE OCCLUDER TO REMOVE THE VENOUS LINE TO GO BACK ON BYPASS. AFTER THE CASE, THE PERFUSIONIST REPOSITIONED THE BOBBINS BACK INTO THE OCCLUDER. THE BOBBINS WERE INITIALLY IN THE CLAMPED POSITION BUT THE VENOUS TILE SHOWED "RELEASED." HE WAS ABLE TO MOVE THE BOBBINS TO RELEASED POSITION, THEN TO CLAMPED AND TO OPEN WITHOUT ISSUE. THIS UNIT WAS REPLACED BY ON SITE BONDED INVENTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281184 ↗
• MalfunctionJan 29, 2025Device Sensing Problem; Device Sensing Problem

  ANNUAL PMS OCCURRED SOMETIME BETWEEN (B)(6) 2023. DURING PMS, CUSTOMER REPORTED RECENT ISSUE WITH LEVEL SENSOR. SPECTRUM FSE TESTED LEVEL SENSOR AND DISCOVERED IT WAS FAULTY. LEVEL SENSOR REPLACED WITH WORKING ON-SITE BONDED INVENTORY. DURING EMERGENT CASE, NEW LEVEL SENSOR DID NOT WORK. NO FURTHER INFORMATION IS AVAILABLE ABOUT THE FAILURE. DURING TROUBLESHOOTING STEPS, THE LEVEL SENSOR WAS MOVED TO THE QVM2 AND RE-PROGRAMMED IN ADMIN MODE FOR MOVE FROM OCCLUDER TO QVM2. LEVEL SENSOR WORKED AS EXPECTED ON QVM2. ALL OTHER OCCLUDER FUNCTIONS WORKING AS EXPECTED. THE LEVEL PORT ON THE OCCLUDER MAY NOT HAVE BEEN FUNCTIONING DURING PMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263752 ↗
• MalfunctionNov 27, 2024Failure to Deliver; Failure to Deliver

  PERFUSIONIST REPORTED THAT THEY WERE UNABLE TO OPEN THE OCCLUDER TO RESUME VENOUS FLOW. WE CONSIDER THE LOSS OF ABILITY TO CONTROL THE PUMP TO BE A REPORTABLE EVENT, DESPITE NO HARM TO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798545 ↗