MPS2 Console 5201260Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 20634624521265), received between Nov 25, 2015 and Sep 24, 2022 — classified as 1 death, 66 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (34 reports).

1 other recall cover devices cleared under the same FDA submission (K041979); they may or may not involve this specific model.

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 67 reports, 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 ↗
• MalfunctionJun 2, 2017Device Operates Differently Than Expected

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS2 CONSOLE DURING USE. THE REPORT STATED THE CONSOLE HAD BEEN INTERMITTENTLY POPPING THE VENT VALVE THROUGHOUT MULTIPLE CASES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. A FIELD SERVICE ENGINEER WILL EVALUATE THE CONSOLE AT THE USER FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6610154 ↗
• MalfunctionMay 14, 2017Device Emits Odor; Noise, Audible

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS CONSOLE DURING USE. HE STATED THAT DURING END OF CASE THAT HE HEARD A LOUD GRINDING NOISE COMING FROM THE CONSOLE. THE REPORT STATED THAT THE CONSOLE WAS IN WARM MODE AND A HEATER/COOLER WAS IN USE. THE PERFUSIONIST STATED HE SMELLED SOMETHING COMING FROM THE CONSOLE BUT CONTINUED TO USE THE CONSOLE TO COMPLETE THE PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 6566085 ↗
• MalfunctionMay 1, 2017Device Displays Incorrect Message

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE HE ENCOUNTERED WITH THE MPS CONSOLE DURING USE. HE STATED THAT THE CONSOLE WAS DISPLAYING AN ERROR CODE FOR "AIR IN HEAT EXCHANGER." THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS ONSITE AND VERIFIED THE OCCURRENCE OF THE ERROR CODE IN THE CONSOLE'S LOG DATA. THE FSE WAS UNABLE TO DUPLICATE THE ISSUE DURING A WET LAB WHILE AT THE FACILITY. THE FSE REPLACED THE FLUID LEVEL SENSOR AS A PREVENTIVE MEASURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6536036 ↗
• MalfunctionApr 10, 2017Device Displays Incorrect Message

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS2 CONSOLE DURING USE. HE REPORTED THAT THE CONSOLE DISPLAYED AN ERROR CODE FOR "RIGHT MOTOR STUCK" WHEN HE WAS ATTEMPTING TO GIVE A HOTSHOT AT THE END OF A PROCEDURE. THE PERFUSIONIST STATED HE PULLED THE CONSOLE FROM USE AND DID NOT GIVE THE HOTSHOT AS A RESULT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE CONSOLE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6478200 ↗
• MalfunctionApr 10, 2017Difficult to Open or Close

  THE HOSPITAL BIOMEDICAL ENGINEER REPORTED AN ISSUE ENCOUNTERED BY THE PERFUSIONIST WHILE USING THE MPS2 CONSOLE. THE REPORT STATED THAT THE CONSOLE'S ANTEGRADE VALVE REMAINED OPEN DURING THE PROCEDURE WHEN IT SHOULD HAVE BEEN CLOSED. 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 6475475 ↗
• MalfunctionApr 7, 2017Device Operates Differently Than Expected

  THE HOSPITAL BIOMEDICAL ENGINEER REPORTED THAT THE PERFUSIONIST ENCOUNTERED AN ISSUE WITH THE MPS CONSOLE DURING USE. THE REPORT STATED THAT THE VENT VALVE REMAINED CONTINUOUSLY OPEN THROUGHOUT A PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME CONSOLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. A FIELD SERVICE ENGINEER WILL EVALUATE THE CONSOLE AT THE USER FACILITY SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6474281 ↗
• MalfunctionApr 7, 2017Device Displays Incorrect Message

  THE BIOMEDICAL ENGINEER REPORTED FOR THE HOSPITAL PERFUSIONIST THAT AN ISSUE WAS ENCOUNTERED WITH THE MPS CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE DISPLAYED AN ALARM FOR "IO CAM REFERENCE NOT FOUND." THE REPORT DID NOT INDICATE AT WHAT POINT IN CONSOLE USE THE ERROR CODE DISPLAYED (SETUP, PRIMING, ON-PUMP). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. A FIELD SERVICE ENGINEER WILL EVALUATE THE CONSOLE AT THE USER FACILITY SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6473552 ↗
• MalfunctionApr 3, 2017Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE HOSPITAL BIOMEDICAL ENGINEER REPORTED AN ISSUE THE PERFUSIONIST ENCOUNTERED WITH THE MPS CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE DISPLAYED AN ALARM CODE FOR "UNKNOWN TEMPERATURE" AND WOULD NOT HEAT. THE REPORT DID NOT STATE AT WHAT POINT DURING PRIMING OR THE PROCEDURE THE ALLEGED ISSUE OCCURRED. INITIAL TROUBLESHOOTING INDICATED THE PROBLEM MAY BE DUE TO A PROBLEMATIC IR SENSOR CAUSING AN INACCURATE TEMPERATURE READING. THE CONSOLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6455540 ↗
• MalfunctionApr 2, 2017Intermittent Continuity; Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE DISPLAYED AN ERROR CODE FOR "AIR IN THE HEAT EXCHANGER." THE REPORT STATED THE ALLEGED ISSUE HAS BEEN OCCURRING INTERMITTENTLY. THE PERFUSIONIST STATED THAT HE UNLOCKS THE DELIVERY SET AND RESETS THE HEAT EXCHANGER WHEN THE ALARM OCCURS AND THIS RESOLVES THE ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE CONSOLE REMAINS IN USE, AND A FIELD SERVICE ENGINEER WILL TRAVEL TO THE FACILITY TO EVALUATE THE CONSOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6451859 ↗
• MalfunctionMar 29, 2017Device Displays Incorrect Message

  THE HOSPITAL BIOMEDICAL ENGINEER REPORTED AN ISSUE ENCOUNTERED WITH THE MPS CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE DISPLAYED AN ERROR CODE FOR "RT MOTOR STUCK AT BOTTOM" AT THE END OF THE PROCEDURE DURING THE LAST WARM DOSE OF CARDIOPLEGIA. THIS REPORT IS FILED OUT OF ABUNDANCE OF PRECAUTION BECAUSE THE COMPLAINT DETAILS DID NOT SPECIFY EXACTLY WHEN THE ALLEGED ISSUE OCCURRED; THAT IS IF THE PATIENT WAS STILL ON BYPASS OR NOT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. IT IS UNKNOWN IF THE CONSOLE WILL RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6445100 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041979. One submission often covers many models, so check the product and lot details in each record.

• Z-1924-2011 · Jul 29, 2010 · Terminated
  Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure