MPS 5001102Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00634624501126), received between Nov 6, 2015 and Jun 14, 2023 — classified as 16 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL BY (B)(6) OF AN ALLEGED ISSUE WITH PRODUCT CODE 5001102. IN THE REPORT, IT WAS STATED THAT BLOOD WAS ALLEGEDLY OBSERVED IN THE HEAT EXCHANGER. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS. LOT NUMBER OF THE DEVICE WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17128549 ↗
• MalfunctionApr 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL BY (B)(6) HOSPITAL, STATING THAT THERE WAS AN ALLEGED POTENTIAL WATER TO BLOOD LEAK IN THE HEAT EXCHANGER. THIS WAS NOTED AFTER CROSS-CLAMP REMOVAL. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820261 ↗
• MalfunctionApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL BY COSMOTEC JAPAN OF AN ALLEGED ISSUE WITH MPS 2 DISPOSABLE SET, PRODUCT CODE 5001102. THE REPORT STATED THAT THERE WAS AN ALLEGED BLOOD LEAK AT THE PRESSURE SENSOR OF THE MPS 2 DELIVERY SET. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792006 ↗
• MalfunctionApr 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  .THE REPORT STATES THAT THE CUSTOMER HAD AN ISSUE WITH PRODUCT 5001102 DURING AN AORTIC VALVE REPLACEMENT. IT WAS REPORTED THAT CONTACT BETWEEN BLOOD AND CIRCULATING WATER WHILE USING MPS2 ON A PATIENT. BLOOD PURIFICATION WAS PERFORMED DURING EXTRACORPOREAL CIRCULATION, AND NO ADVERSE EVENT OCCURRED WITH THE PATIENT. THE MPS DELIVERY SET IN QUESTION WAS DISCONTINUED AND ANOTHER CIRCUIT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726399 ↗
• MalfunctionJul 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST THAT AN MPS DELIVERY SET ALLEGEDLY WAS LEAKING BLOOD INTO THE HEAT EXCHANGER. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14949824 ↗
• MalfunctionJul 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL THAT THERE WAS AN MPS DELIVERY SET THAT WAS ALLEGEDLY LEAKING BLOOD AT THE BOTTOM OF THE MACHINE, BY THE DOOR. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946345 ↗
• MalfunctionFeb 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A REPORT WAS RECEIVED FROM A CUSTOMER STATING THAT THERE WAS OBSERVED TO BE AN ALLEGED LIQUID LEAKAGE IN THE MPS SET DURING THE SURGERY. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506193 ↗
• MalfunctionAug 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AN INCIDENT WAS REPORTED WHERE THE REPORTER EMAILED A PICTURE TO CUSTOMER SERVICE. THE REPORTER SAID THAT THEY NOTICED BLOOD MIGRATION INTO THE HEAT EXCHANGER IN A WAY THEY HAD NOT SEEN BEFORE. THERE WERE NO PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467430 ↗
• MalfunctionSep 11, 2017Defective Component

  THE HOSPITAL BIOMEDICAL ENGINEER REPORTED FOR THE PERFUSIONIST THAT AN ISSUE WAS ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. THE REPORT STATED THAT DURING A PROCEDURE THE ADDITIVE AND ARREST AGENT CASSETTES COMPLETELY EMPTIED OUT ON BOTH SIDES. THE REPORT STATED THAT TROUBLESHOOTING OVER THE PHONE DETERMINED THE ISSUE WAS WITH THE DELIVERY SET RATHER THAN WITH THE CONSOLE. 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 6854466 ↗
• MalfunctionSep 1, 2017Leak/Splash

  THE SALES REPRESENTATIVE REPORTED AN ISSUE ENCOUNTERED BY THE HOSPITAL PERFUSIONIST WITH THE MPS DELIVERY SET. THE REPORT STATED THE PERFUSIONIST DISCOVERED THAT THE LINE HAD A PIN-HOLE LEAK THAT WAS CAPABLE OF LEAKING BLOOD AND ASPIRATING AIR. SHE STATED THE LINE WAS CHANGED OUT BEFORE ANY AIR WAS DELIVERED TO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6840453 ↗
• MalfunctionAug 10, 2017Failure to Deliver; Positioning Problem

  THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE REPORTED TO THEM FROM THEIR CUSTOMER WITH AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. THE REPORT STATED "THE GREEN TAB OF THE STOPCOCK WAS OVER ROTATED TO THE UNUSUAL POSITION." THE REPORT ALSO STATED THAT WHEN THE CLINICAL STAFF ATTEMPTED TO INJECT ADDITIVE AGENT INTO ADDITIVE CASSETTE, THE ADDITIVE AGENT INJECTED TO THE PATIENT ACCIDENTALLY BECAUSE THE GREEN TAB OF THE STOPCOCK WAS LOCATED IN AN OPPOSITE POSITION. THE REPORT STATED THE CLINICAL STAFF POSSIBLY CONFIRM THE DIRECTION OF GREEN TAB CAREFULLY. AS A RESULT OF THE ALLEGED ISSUE, THE CLINICAL STAFF ATTEMPTED TO WASHOUT THE ADDITIVE AGENT WHICH INJECTED THE PATIENT BODY WITH USING 2,000 ML OF BLOOD (BLOOD AND POTASSIUM). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783799 ↗
• MalfunctionJul 11, 2017Device Contamination with Body Fluid

  THE FOREIGN DISTRIBUTOR ((B)(4)) REPORTED AND ISSUE THEIR CUSTOMER ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. THE REPORT STATED THAT FOLLOWING THE SURGICAL PROCEDURE THE MEDICAL STAFF REMOVED THE DELIVERY SET FROM THE CONSOLE AND FOUND BLOOD ON THE PRESSURE SENSOR (OF THE CONSOLE). THE PROCEDURE WAS COMPLETED WITH NO PROBLEM, BUT THE CUSTOMER SUSPECTS A LEAK FROM PRESSURE SENSOR AREA OF THE DELIVERY SET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6700003 ↗
• MalfunctionJun 28, 2017Leak/Splash

  THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. THE REPORT FROM THEIR CUSTOMER STATED THAT DURING PRIMING A LEAK WAS OBSERVED FROM THE ARREST AGENT STOPCOCK. THE REPORT STATED THE DELIVERY SET WAS DISCARDED AND NOT 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 6676144 ↗
• MalfunctionMay 1, 2017Leak/Splash

  THE INTERNATIONAL DISTRIBUTOR (B)(6) REPORTED AN ISSUE ENCOUNTERED BY THEIR CUSTOMER WITH THE MPS DELIVERY SET DURING PRIMING. THE REPORT STATED THEY OBSERVED A LEAK FROM BACKSIDE OF THE THREE-WAY STOPCOCK OF THE ARREST CASSETTE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6536019 ↗
• MalfunctionApr 13, 2017Leak/Splash

  THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED BY THEIR CUSTOMER WHILE USING THE MPS DELIVERY SET. THE REPORT STATED THAT DURING THE PROCEDURE THE SURGICAL STAFF OBSERVED A LEAK FROM THE BACKSIDE OF THE THREE-WAY STOPCOCK ON THE ARREST CASSETTE APPROXIMATELY 2-3 MINUTES FROM START OF USE. THE STAFF REMOVED THE CASSETTE AND USED THE ADDITIVE CASSETTE FROM THE SAME DELIVERY SET TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE CASSETTE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6490325 ↗
• MalfunctionApr 4, 2017Device Contamination with Chemical or Other Material

  THE INTERNATIONAL DISTRIBUTOR ((B)(6)) REPORTED AN ISSUE THEIR CUSTOMER ENCOUNTERED WITH THE MPS DELIVERY SET UPON SETTING UP FOR A PROCEDURE. THE REPORT STATED THAT THE CLINICAL STAFF OBSERVED WHITE PARTICULATE MATTER IN THE ARREST CASSETTE. THE REPORT STATED ANOTHER DELIVERY SET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DELIVERY SET WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6457355 ↗
• MalfunctionMar 31, 2017Particulates

  THE FOREIGN DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED WITH THE DELIVERY SET BY THEIR END-USE CUSTOMER. THE REPORT STATED THAT THEIR CUSTOMER OBSERVED GREEN-COLORED PARTICULATE MATTER IN THE ADDITIVE CASSETTE OF THE DELIVERY SET. THE DELIVERY SET WAS CHANGED OUT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DELIVERY SET WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6451282 ↗
• MalfunctionMar 23, 2017Device Contamination with Chemical or Other Material

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE DELIVERY SET DURING USE. THE REPORT STATED THAT WHEN THE DELIVERY SET LINES WERE HANDED TO THE PERFUSIONIST PRIOR TO THE PROCEDURE STARTING, HE OBSERVED PARTICULATE MATTER WHEN HE FLUSHED TO THE STERILE FIELD. THE DELIVERY SET WAS CHANGED OUT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DELIVERY SET WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6428540 ↗
• InjuryMar 2, 2017Fluid/Blood Leak

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE DELIVERY SET DURING USE. THE REPORT STATED THAT THE DELIVERY SET HAD A PRESSURE DIAPHRAGM BLOOD LEAK. THERE WERE NO ADDITIONAL DETAILS PROVIDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Blood Loss

  MAUDE report 6373053 ↗
• MalfunctionFeb 7, 2017Leak/Splash

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE DELIVERY SET. THE REPORT STATED THAT THE DEVICE HAD A LEAK AT THE STOPCOCK OF THE ARREST AGENT CASSETTE. THE REPORT STATED THE ISSUE WAS DISCOVERED PRIOR TO GOING ON BYPASS, AND ANOTHER SET WAS OPENED AND USED FOR THE PROCEDURE INSTEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6307398 ↗
• MalfunctionFeb 3, 2017Leak/Splash

  THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE THEIR CUSTOMER ENCOUNTERED WHILE USING THE DELIVERY SET. THE REPORT STATED THAT DURING AN EMERGENCY SURGERY, THE BACKSIDE OF THE THREE-WAY STOPCOCK OF THE ARREST POUCH CONTAINING POTASSIUM LEAKED. THE REPORT STATED THE CLINICIANS DECIDED TO USE THE DELIVERY SET TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6302630 ↗
• MalfunctionJan 11, 2017Device Contamination with Chemical or Other Material

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH AN MPS DELIVERY SET FOUND PRIOR TO USE IN A PROCEDURE. THE REPORT STATED THAT THE CLINICAL STAFF OBSERVED PARTICULATE MATTER IN THE DELIVERY LINE, DISTAL TO THE FILTER, FLOATING IN THE PRIMING SOLUTION. THE REPORT STATED THE CLINICAL STAFF DISCARDED THE DELIVERY SET AND USED ANOTHER ONE INSTEAD FOR THE PROCEDURE. THE DELIVERY SET WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AND NO PHOTOGRAPHS WERE TAKEN. FOLLOW-UP WITH THE COMPLAINANT FOUND THAT THE ALLEGED PARTICULATE WAS WHITE IN COLOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6241287 ↗
• InjuryNov 30, 2016Fluid/Blood Leak

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. HE STATED THAT THE DELIVERY SET LEAKED BLOOD. THERE WERE NO FURTHER DETAILS PROVIDED AS TO WHEN THE ALLEGED EVENT OCCURRED DURING THE PROCEDURE OR THE AMOUNT OF BLOOD LOST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6136297 ↗
• InjuryNov 14, 2016Leak/Splash

  THE INTERNATIONAL ((B)(4)) DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS WHILE USING THE MPS DELIVERY SET. THE REPORT STATED THE PROCEDURE WAS A RETHORACTOMY AFTER AVR (AORTIC VALVE REPLACEMENT), AND THAT DURING THE PROCEDURE A LEAK FROM THE BLOOD OUTLET SIDE OF THE PUMP CASSETTE WAS OBSERVED. THE REPORT STATED THAT THE HOSPITAL HAD TO OBTAIN ANOTHER DELIVERY SET FROM ANOTHER FACILITY TO USE FOR THE PROCEDURE. THE REPORT STATED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6100886 ↗
• MalfunctionNov 1, 2016Device Contamination With Biological Material

  THE HOSPITAL PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS DELIVERY SET DURING USE. HE REPORTED THAT TRACES OF BLOOD WERE OBSERVED ON THE SURFACE OF THE BELLOWS OF THE HEAT EXCHANGER. THE REPORT INDICATED THIS WAS FOUND AT THE END OF THE PROCEDURE WHILE WARMING. THE REPORT STATED THAT NO BLOOD WAS OBSERVED IN THE WATER SOURCE, NOR WAS WATER IN THE BLOOD SOURCE DETECTED. THE REPORT FURTHER STATED THE INCIDENT DID NOT CAUSE A DELAY IN THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DELIVERY SET WAS DISCARDED BY THE FACILITY AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6071388 ↗

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