MPS2 ConsoleRecalls & reported problems across all models
Quest Medical Inc · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 69
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of MPS2 Console by Quest Medical Inc in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Nov 25, 2015 and Sep 24, 2022 — classified as 1 death, 68 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported MPS2 Console problems
Device problems
- Device Displays Incorrect Message36
- Device Operates Differently Than Expected15
- Loss of Power5
- Fluid/Blood Leak4
- Failure to Prime3
- Infusion or Flow Problem3
- Mechanical Problem3
- Sticking3
Patient problems
- No Known Impact Or Consequence To Patient44
- No Consequences Or Impact To Patient22
- Blood Loss1
- Death1
- Irregular Pulse1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
MPS2 Console models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MPS2 Console 5201260Heat-Exchanger, Cardiopulmonary Bypass1 death67 reports
- MPS2 console 5202260Heat-Exchanger, Cardiopulmonary Bypass2 reports
Recent MPS2 Console adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2022Backflow; No Apparent Adverse Event; Backflow; No Apparent Adverse Event
IT WAS REPORTED TO QUEST MEDICAL OF AN ALLEGED ISSUE WITH AN MPS CONSOLE. THE USER STATED THAT DURING CARDIOPLEGIA DELIVERY, BACK FLOW WAS NOTICED. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15481105 ↗MalfunctionJun 14, 2018Fluid/Blood Leak; Device Displays Incorrect Message; Fluid/Blood Leak
A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE WHICH OCCURRED WITH THE MPS 2 CONSOLE. THE REPORT STATES THAT THE CONSOLE DISPLAYED EC 225 AND ISSUED THE FOLLOWING ALARMS: INSUFFICIENT BLOOD INLET AND EXCESSIVE BLOOD INLET. NO PATIENT COMPLICATIONS RESULTED FROM THE ALLEGED ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7600906 ↗MalfunctionJun 14, 2018Loss of Power; Failure to Power Up; Complete Loss of Power; Complete Loss of Power
A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE WHICH OCCURRED WITH THE MPS 2 CONSOLE. THE REPORT STATES THAT WHILE SETTING UP FOR A CASE, THE CONSOLE LOST POWER. A SECOND ATTEMPT WAS MADE AT A DIFFERENT LOCATION AND IT STILL DID NOT POWER ON. THE DEVICE WAS NOT USED ON A PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7600896 ↗MalfunctionMay 1, 2018Loss of Power; Failure to Power Up
A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE WHICH OCCURRED WITH THE MPS 2 CONSOLE. THE REPORT STATES THAT WHILE PRIMING, THE CONSOLE POWERED OFF AND WOULD NOT POWER BACK ON. THE CONSOLE WAS PLUGGED IN A DIFFERENT OUTLET AND THE ISSUE SUBSISTED. THE DEVICE WAS NOT USED ON A PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7476627 ↗MalfunctionFeb 7, 2018Loss of Power; No Apparent Adverse Event; No Apparent Adverse Event
DURING ANNUAL PREVENTIVE MAINTENANCE, THE CONSOLE WAS REPORTED TO HAVE SUDDENLY LOST POWER WHILE IT WAS BEING INSTALLED. THE DEVICE WAS NOT USED ON A PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7248179 ↗MalfunctionNov 8, 2017Device Displays Incorrect Message
THE HOSPITAL BIOMEDICAL ENGINEER REPORTED FOR PERFUSION THAT AN ISSUE WAS ENCOUNTERED WITH THE MPS2 CONSOLE DURING USE. THE REPORT STATED THAT THE PERFUSIONIST WAS GIVING THE INITIAL DOSE AND GOT AN ALARM MESSAGE. THE PERFUSIONIST STATED THAT SHE KEPT RECEIVING THE ALARM AFTER POWERING OFF AND BACK ON. THE PERFUSIONIST STATED SHE USED ANOTHER CONSOLE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE CONSOLE IS EXPECTED TO RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7011846 ↗MalfunctionAug 29, 2017Solder Joint Fracture; Mechanical Problem; Sticking; Solder Joint Fracture
THE HOSPITAL BIOMEDICAL ENGINEER REPORTED FOR PERFUSION THAT AN ISSUE OCCURRED WITH THE MPS CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE WAS POPPING THE VENT VALVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE BIOMEDICAL ENGINEER STATED HE TOOK THE LOCKING KNOB OFF TO OPEN THE UNIT TO CHECK THE CONNECTION FOR THE FLUID LEVEL SENSOR AND WHEN HE TOOK THE SCREWS OUT, ONE OF THE SCREWS HAD THE HELI COIL WITH IT. THE CONSOLE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6829425 ↗MalfunctionAug 28, 2017Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem
THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS CONSOLE DURING USE. HER REPORT STATED THE CONSOLE HAD DISPLAYED EC004 "INTERNAL ERROR" WHILE ON BYPASS. THE PERFUSIONIST REPORTED THE CONSOLE WAS SUCCESSFULLY POWER CYCLED AFTER A FEW ATTEMPTS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. A FIELD SERVICE ENGINEER WILL TRAVEL TO THE ACCOUNT TO EVALUATE THE CONSOLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6823315 ↗MalfunctionAug 21, 2017Fluid/Blood Leak; Hole In Material; Leak/Splash; Detachment Of Device Component; Fluid/Blood Leak; Hole In Material; Leak/Splash
THE BIOMEDICAL ENGINEER REPORTED AN ISSUE ENCOUNTERED WITH THE MPS2 CONSOLE DURING USE. THE REPORT STATED THE CONSOLE CONTINUOUSLY POPPED THE VENT VALVE, AND THE USER WOULD HAVE TO MANUALLY CLAMP THE VENT LINE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE CONSOLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6809376 ↗MalfunctionAug 21, 2017Sticking; Positioning Problem; Sticking; Device Displays Incorrect Message; Positioning Problem
THE PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS2 CONSOLE DURING USE. THE REPORT STATED THE CONSOLE HAD DISPLAYED THE ERROR CODE FOR "EXCESS AIR IN HEX" AND HAD TO BE MANUALLY CLAMPED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. A FIELD SERVICE ENGINEER WILL EVALUATE THE CONSOLE AT THE USER'S FACILITY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6809372 ↗MalfunctionJul 23, 2017Self-Activation or Keying
THE PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE WAS OPENING THE VENT VALVE CONTINUOUSLY. THE REPORT STATED THE PERFUSIONIST CLAMPED THE VENT LINE AND SUCCESSFULLY COMPLETED THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE CONSOLE WAS RETURNED TO THE MANUFACTURER EVALUATION/REPAIR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6735021 ↗MalfunctionJun 25, 2017Loss of Power; Device Displays Incorrect Message
THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS 2 CONSOLE DURING USE. THE REPORT STATED THE CONSOLE PRIMED FINE BUT SUDDENLY STARTED DISPLAYING OVER PRESSURE ALARMS AND WOULD SHUT OFF FLOW. THE REPORT STATED THE PERFUSIONIST WANTED THE CONSOLE TO BE EVALUATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE CONSOLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6666117 ↗MalfunctionJun 25, 2017Failure to Deliver; Device Displays Incorrect Message; Infusion or Flow Problem
THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WHILE USING THE MPS-2 CONSOLE. THE REPORT STATED THE CONSOLE WAS DISPLAYING AN "ARREST AGENT PUMP OCCLUDED" ALARM AND THE CONSOLE WAS ALSO NOT DELIVERING THE PROPER AMOUNT OF POTASSIUM. THE REPORT STATED A CALL WITH THE MANUFACTURER RECOMMENDED TO HIM TO REPLACE HIS ARREST POUCH BUT AT THE TIME OF THE CALL THE PROCEDURE HAD ALREADY COMPLETED. THE PERFUSIONIST STATED HE REMOVED THE ARREST POUCH TO SEE IF THERE WERE ANY SIGNS OF OCCLUSIONS AND SAID HE HAD TO "SQUEEZE VERY HARD TO GET ANY FLUID TO FLOW OUT." THE PERFUSIONIST REQUESTED TO HAVE THE CONSOLE (SERIAL NUMBER NOT PROVIDED) CHECKED OUT ONSITE BY A FIELD SERVICE ENGINEER. THERE WAS NO INFORMATION ON WHETHER OR NOT THE ALLEGED ISSUE CAUSED ANY PATIENT COMPLICATIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6666113 ↗MalfunctionJun 19, 2017Device Operates Differently Than Expected
THE HOSPITAL BIOMEDICAL ENGINEER REPORTED AN ISSUE WITH THE MPS2 CONSOLE DURING USE. THE REPORT STATED THAT THE PERFUSION DEPARTMENT HAD ISSUES WITH THE CONSOLE POPPING THE VENT VALVE DURING MORE THAN ONE PROCEDURE. THE REPORT STATED THAT CHANGING THE DELIVERY SET DID NOT CAUSE THE ISSUE TO STOP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6652733 ↗MalfunctionJun 7, 2017Device Displays Incorrect Message
THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS2 CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE DISPLAYED AN ERROR CODE "ADDITIVE UNDER DELIVERY." THE REPORT STATED THIS OCCURRED THROUGHOUT THE PROCEDURE BUT THE STAFF WAS TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE CONSOLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6619384 ↗
Other Quest Medical Inc products
All Quest Medical Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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