MPS Console 5001000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20634624501007), received between Sep 14, 2016 and May 18, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K953838); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2017Improper Device Output

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE DISPLAYED REALLY LOW, AND SOMETIMES ZERO, PRESSURE DURING DELIVERY. 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 6574542 ↗
• MalfunctionApr 4, 2017Detachment Of Device Component; Intermittent Continuity

  THE HOSPITAL EQUIPMENT COORDINATOR REPORTED AN ISSUE ENCOUNTERED WITH THE MPS CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE HAD BEEN INTERMITTENTLY POPPING THE VENT VALVE WHILE DELIVERY CARDIOPLEGIA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. A FIELD SERVICE ENGINEER WILL TRAVEL TO THE USER FACILITY TO EVALUATE THE CONSOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6457761 ↗
• MalfunctionMar 2, 2017Device Displays Incorrect Message

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE WITH THE MPS CONSOLE DURING USE. SHE REPORTED THAT THE CONSOLE ALARMED AND DISPLAYED AN ERROR CODE FOR "INTERNAL TIMING ERROR" DURING THE INDUCTION DOSE OF ARREST AGENT. THE REPORT STATED THAT THE CONSOLE DISPLAYED THE ERROR FOUR TIMES BEFORE REMAINING ON. 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 6372922 ↗
• MalfunctionSep 14, 2016Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE HOSPITAL BIOMEDICAL ENGINEER REPORTED AN ISSUE WITH THE MPS CONSOLE DURING USE. HE REPORTED FOR PERFUSION THAT THE CONSOLE WOULD REPEATEDLY DISPLAY AN ERROR CODE AND WOULD OPEN THE VENT VALVE DURING CARDIOPLEGIA DELIVERY. THE REPORT STATED THAT THE CONSOLE WAS USED TO COMPLETE THE PROCEDURE WITH THE PERFUSIONIST MANUALLY CLAMPING THE VENT LINE CLOSED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE CONSOLE WILL BE EVALUATED BY A FIELD SERVICE ENGINEER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5950956 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953838. One submission often covers many models, so check the product and lot details in each record.

• Z-0361-2016 · Oct 28, 2015 · Terminated
  Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7
• 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
• Z-1037-03 · May 23, 2003 · Terminated
  Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes