MPSRecalls & reported problems across all models
Quest Medical Inc · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 2 models of MPS by Quest Medical Inc in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2015 and Jun 14, 2023 — classified as 18 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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 MPS problems
Device problems
- Fluid/Blood Leak24
- Leak/Splash14
- Nonstandard Device6
- Device Contamination with Chemical or Other Material3
- Device Displays Incorrect Message2
- Failure to Prime2
- Application Program Problem1
- Defective Component1
Patient problems
- No Known Impact Or Consequence To Patient28
- No Clinical Signs, Symptoms or Conditions9
- Blood Loss8
- No Consequences Or Impact To Patient2
- No Patient Involvement2
- Cardiac Arrest1
- No Code Available1
MPS models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MPS 5001102Heat-Exchanger, Cardiopulmonary Bypass42 reports
- MPS 5001102-ASHeat-Exchanger, Cardiopulmonary Bypass7 reports
Recent MPS adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page