MPS 5001102-ASRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00634624521124), received between Mar 23, 2016 and Feb 2, 2022 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A REPORT WAS RECEIVED FROM A CUSTOMER REGARDING AN ALLEGED ISSUE WHICH OCCURED DURING USE OF THE DEVICE. THE REPORT STATES THAT, DURING THE SURGERY, AN ALLEGED LEAK WAS FOUND FROM THE CHAMBER ARREST CHAMBER, WHERE THE TUBE LEAVES THE BAG. AS A RESULT, ADDITIONAL CARDIOPLEGIA SOLUTION WAS REQUIRED TO BE ADMINISTERED. IT WAS CONFIRMED WITH THE CUSTOMER THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423384 ↗
• MalfunctionJul 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO (B)(6) BY UNIVERSITY HOSPITAL ((B)(6)) THAT, AFTER PRIMING OF THE MPS DISPOSABLE SET, THE FLUID LEVEL IN THE RESERVOIR WAS NOTICEABLY HIGHER AND THE WATER LEVEL IN THE HEATER/COOLER WAS LOWER THAN AT START OF PRIMING, INDICATING A LEAK. THE DISPOSABLE WAS REMOVED AND REPLACED PRIOR TO RUNNING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103753 ↗
• MalfunctionDec 28, 2016Fluid/Blood Leak

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. THE REPORT STATED THAT PRIOR TO GOING ON PUMP (BYPASS ON HEART/LUNG MACHINE) SHE OBSERVED THE YELLOW ARREST-AGENT STOPCOCK HAD A VERY SLOW LEAK. THE REPORT STATED THIS WAS FOUND WHILE THE PERFUSIONIST WAS ADMINISTERING CARDIOPLEGIA AND ALSO WHILE THE UNIT WAS NOT DELIVERING CARDIOPLEGIA (THAT IS, IT WAS A CONTINUOUS LEAK). THE LEAKED FLUID WAS POTASSIUM ONLY WITH THE ESTIMATED VOLUME LOST WAS 5 MLS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DELIVERY SET WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6210300 ↗
• MalfunctionSep 7, 2016Leak/Splash

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. THE REPORT ONLY STATED THAT THE DISPOSABLE DEVICE LEAKED. THERE WERE NO OTHER DETAILS PROVIDED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5934559 ↗
• InjuryApr 28, 2016Fluid/Blood Leak

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH AN MPS DELIVERY SET DURING USE. THERE WERE TWO INCIDENTS DURING THE SAME DAY, WITH DEVICES FROM THE SAME LOT. REFERENCE MANUFACTURER REPORT NUMBER 1649914-2016-00017 FOR THE FIRST INCIDENT. THIS REPORT STATED THAT FOR THIS SECOND INCIDENT WHEN SHE HAD ADMINISTERED OVER 1.5 LITERS OF FLUID BUT NOTICED THE HEART WAS STILL NOT ARRESTING WHEN IT USUALLY ARRESTS AROUND 300ML, SHE LOOKED DOWN AND SAW THE LEAK. SHE STATED THAT SHE HAD TO TURN UP THE AMOUNT OF MEQ/L BECAUSE THE HEART WAS ARRESTING A LITTLE BUT NOT COMPLETELY SO SHE KNEW SOME OF THE MEDICATION WAS GOING IN. THE REPORT STATED THAT ONCE SHE TURNED IT UP SHE WAS ABLE TO FINALLY ARREST THE HEART COMPLETELY AND THEN FROM THAT POINT ON AND MOVED THE ARREST AGENT MEDICATION OVER TO THE ADDITIVE SIDE LIKE SHE DID FOR THE FIRST INCIDENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5618260 ↗
• MalfunctionApr 28, 2016Device Operates Differently Than Expected

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH AN MPS DELIVERY SET DURING USE. THERE WERE TWO INCIDENTS DURING THE SAME PROCEDURE, WITH DEVICES FROM THE SAME LOT. REFERENCE MANUFACTURER REPORT NUMBER 1649914-2016-00018 FOR THE SECOND INCIDENT. THIS REPORT STATED THAT FOR THIS FIRST INCIDENT THERE WAS NO LOSS OF MEDICATION BECAUSE THE ARREST AGENT DID NOT GET PAST THE POINT WHERE THE MEDICATION JOINS WITH THE BLOOD IN THE SET. THE ISSUE OCCURRED WHILE THE CROSS CLAMP WAS IN PLACE BUT PRIOR TO DELIVERY OF THE ARREST AGENT. THE PERFUSIONIST STATED THAT AS A RESULT SHE NOTIFIED THE SURGEON WHO REMOVED THE CROSS CLAMP WHILE SHE ATTEMPTED TO TROUBLESHOOT. THE PERFUSIONIST STATED THAT IN ORDER TO ARREST THE HEART SHE REMOVED SOME ADDITIVE FLUID FROM THE ADDITIVE CASSETTE AND REPLACE IT WITH ARREST AGENT AND USED THAT ADDITIVE CASSETTE FOR THE REST OF THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5618179 ↗
• InjuryMar 23, 2016Fluid/Blood Leak

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. IT WAS REPORTED THAT THE DELIVERY SET LEAKED WHERE THE CONNECTOR ENTERS THE POUCH ON THE LEFT HAND SIDE. FOLLOW UP WITH THE COMPLAINANT FOUND THAT THERE WAS AN ESTIMATED 150-200 ML BLOOD LOSS DUE TO THE LEAK. THEY STATED THAT IT WAS FOUND WHILE THE PATIENT WAS ON BYPASS JUST BEFORE THE CROSS CLAMP WAS PLACED. THE PERFUSIONIST REPORTED THEY SAW THE LEAKED BLOOD UNDER THE MPS CONSOLE, INFORMED THE SURGEON, CLAMPED THE LINES AND INVESTIGATED TO FIND THE SOURCE OF THE LEAK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

  Patient problems: Blood Loss

  MAUDE report 5520698 ↗

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