The Belmont® Rapid Infuser FMS2000 903-00001Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10896128002012), received between Nov 6, 2015 and Sep 22, 2023 — classified as 2 deaths, 47 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K032674); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2023Overheating of Device; Smoking; Overheating of Device; Smoking

  THE BIOMED REPORTED THAT DURING A PROCEDURE, THE NURSE NOTICED ELECTRICAL BURNING SMELL AND SMOKE COMING FROM FMS 2000. THE DEVICE ALSO HAD AN ERROR MESSAGE ON THE SCREEN. ALTHOUGH THE PATIENT INVOLVED IN THE INCIDENT EXPIRED, THE USER FACILITY CONFIRMED THAT MTP WAS A LIFESAVING ATTEMPT AND THE PATIENT WAS VERY ILL BEFOREHAND. THE MALFUNCTIONING OF THE MACHINE DID NOT IMPACT THE OUTCOME OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17803740 ↗
• MalfunctionDec 17, 2021Excessive Heating; Excessive Heating

  THE USER FACILITY REPORTED THAT THE RAPID INFUSER, FMS 2000 "OVERHEATED." THE PATIENT DECEASED, HOWEVER IT WAS REPORTED THAT THE DEATH WAS NOT DUE TO THE SYSTEM OR TO THE REPORTED OVERHEAT.

  Patient problems: Insufficient Information

  MAUDE report 13031937 ↗
• MalfunctionAug 5, 2021Failure to Infuse; Failure to Infuse

  THE HOSPITAL BIOMED REPORTED THAT THE USER WAS UNABLE TO USE THE RAPID INFUSER, FMS 2000 ON A PATIENT DURING A CASE ON (B)(6) 2021 LATE AFTERNOON. ACCORDING TO THE REPORT: A BLOOD BAG WAS CONNECTED TO THE FMS MACHINE. AFTER FINISH PRIMING, 500 ML/MIN FLOW RATE WAS SELECTED BUT THE UNIT WAS AT IDLE AND NOT PROCEEDING TO INFUSE. THERE WAS NO ERROR MESSAGE ON THE SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284893 ↗
• MalfunctionJul 9, 2021Excessive Heating; Excessive Heating

  THE HOSPITAL BIOMED REPORTED THE FOLLOWING INCIDENT INVOLVING A BELMONT RAPID INFUSER, FMS 2000: "ON (B)(6) 2021 WE HAD A TRAUMA ARRIVE AT OUR FACILITY. PATIENT STARTED IN THE ER AND THEN WENT TO THE OR. MASSIVE TRANSFUSIONS WERE CALLED IN ER AND OR. ER AND OR EACH HAVE THEIR OWN BELMONT RAPID INFUSERS. NO PROBLEMS OCCURRED IN THE ER. CASE STARTED IN OR WITH S/N (B)(4) AND AFTER MULTIPLE UNITS OF BLOOD UNIT OVERHEATED. STAFF ATTEMPTED TO KEEP USING THIS DEVICE BUT KEPT OVERHEATING. STAFF THEN BROUGHT IN S/N (B)(4) AND HAD THE SAME RESULTS. THERE WAS NOT AN ADVERSE OUTCOME. FROM TALKING TO THE STAFF THEY DID NOT CHANGE TUBING SETS AS RECOMMENDED IN THE MANUAL." THIS REPORT IS FOR SERIAL NUMBER (B)(4); A SEPARATE REPORT WILL BE ENTERED FOR SERIAL NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146340 ↗
• MalfunctionJul 9, 2021Excessive Heating; Excessive Heating

  THE HOSPITAL BIOMED REPORTED THE FOLLOWING INCIDENT INVOLVING A BELMONT RAPID INFUSER, FMS 2000: "ON (B)(6) 2021 WE HAD A TRAUMA ARRIVE AT OUR FACILITY. PATIENT STARTED IN THE ER AND THEN WENT TO THE OPERATING ROOM (OR). MASSIVE TRANSFUSIONS WERE CALLED IN ER AND OR. ER AND OR EACH HAVE THEIR OWN BELMONT RAPID INFUSERS. NO PROBLEMS OCCURRED IN THE ER. CASE STARTED IN OR WITH S/N (B)(4) AND AFTER MULTIPLE UNITS OF BLOOD UNIT OVERHEATED. STAFF ATTEMPTED TO KEEP USING THIS DEVICE BUT KEPT OVERHEATING. STAFF THEN BROUGHT IN S/N (B)(4) AND HAD THE SAME RESULTS. THERE WAS NOT AN ADVERSE OUTCOME. FROM TALKING TO THE STAFF THEY DID NOT CHANGE TUBING SETS AS RECOMMENDED IN THE MANUAL." THIS REPORT IS FOR SERIAL NUMBER (B)(4); A SEPARATE REPORT WILL BE ENTERED FOR SERIAL NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146324 ↗
• MalfunctionJun 9, 2021Power Problem; Power Problem

  THE USER FACILITY REPORTED THAT THE BELMONT RAPID INFUSER, FMS 2000 WAS TRIPPING THE CIRCUIT BREAKER DURING A CASE IN THE EMERGENCY ROOM. ANOTHER RAPID INFUSER WAS BROUGHT IN TO FINISH THE CASE AND THE PATIENT WAS NOT HARMED. THE UNIT FAILED THE ELECTRICAL SAFETY ANALYZER IN THE BIOMED DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970980 ↗
• MalfunctionApr 30, 2021Device Fell; Excessive Heating; Device Fell; Excessive Heating

  THE USER FACILITY REPORTED THAT THE RAPID INFUSER, FMS 2000 EXHIBITED AN "OVER TEMPERATURE" ALARM WHILE TREATING A TRAUMA PATIENT. THE HOSPITAL BIOMED ALSO REPORTED THAT THE SYSTEM WAS DROPPED. THERE IS DAMAGE TO THE HOUSING AND THE TOUCH SCREEN IS NOT FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757983 ↗
• MalfunctionApr 28, 2021Insufficient Heating; Insufficient Heating

  THE USER FACILITY REPORTED THAT THE RAPID INFUSER, FMS 2000 EXHIBITED A "HEATING FAULT" ALARM DURING A CASE. ANOTHER RAPID INFUSER WAS BROUGHT IN TO FINISH THE CASE; THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741196 ↗
• MalfunctionMar 7, 2021Fluid/Blood Leak; Excessive Heating; Fluid/Blood Leak; Excessive Heating

  BELMONT'S SALES REPRESENTATIVE RECEIVED A REPORT FROM THE USER FACILITY THAT THE BELMONT RAPID INFUSER, FMS 2000 "BEGAN TO SMOKE AND THE DISPOSABLE BEGAN TO LEAK BLOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426362 ↗
• MalfunctionFeb 13, 2021Intermittent Loss of Power; Intermittent Loss of Power

  THE USER FACILITY REPORTED THAT THE RAPID INFUSER, FMS 2000 SHUT DOWN MOMENTARILY DURING A CASE. THE USER WAS ABLE TO REPOWER THE UNIT AND COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325945 ↗
• MalfunctionDec 31, 2020Excessive Heating; Excessive Heating

  BELMONT'S DISTRIBUTOR RECEIVED A REPORT FROM THE USER FACILITY THAT A BURNING ODOR WAS NOTED AFTER INFUSING 200ML OF PRBCS AND WARMED PLASMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103306 ↗
• MalfunctionNov 6, 2020Increase in Pressure; Failure to Infuse; Increase in Pressure; Failure to Infuse

  BELMONT RECEIVED A MEDWATCH REPORT (UF/IMPORTER REPORT # (B)(4)) FROM THE DEPARTMENT OF HEALTH & HUMAN SERVICES, ABOUT AN EVENT THAT REPORTEDLY OCCURRED ON (B)(4) 2020: "DURING A CODE RED TRAUMA, MASS TRANSFUSION WAS ORDERED ON THE PATIENT. THE BELMONT RAPID INFUSER MALFUNCTIONED AND DID NOT INFUSE BLOOD AS NEEDED FOR THE PATIENT'S CARE EFFORTS. INSTEAD, THE BELMONT RAPID INFUSER WOULD ONLY ALARM HIGH PRESSURE AND STOP EVERY FEW SECONDS."

  Patient problems: Insufficient Information

  MAUDE report 10805231 ↗
• MalfunctionJan 29, 2020Temperature Problem; Temperature Problem

  THE USER FACILITY REPORTED THAT THE RAPID INFUSER EXPERIENCED AN "OVERTEMP" ALARM AFTER A FEW HOURS INTO A CASE. THE UNIT WAS SUBSEQUENTLY BROUGHT TO THE BIOMED LAB AND BEGAN EXHIBITING A CONSTANT "HEATER POWER I/O FAULT" ALARM.

  Patient problems: No Information

  MAUDE report 9644353 ↗
• MalfunctionJan 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE HOSPITAL BIOMED REPORTED THAT THE OVERNIGHT STAFF EXPERIENCED A "PROBLEM" WHILE USING THE RAPID INFUSER ON A PATIENT. BY THE TIME THEY WERE ABLE TO RETRIEVE ANOTHER BELMONT, THE PATIENT HAD "BLED OUT". THE STAFF DID NOT PROVIDE THE BIOMED WITH ANY FURTHER DETAILS, OTHER THAN THERE MAY HAVE BEEN AN "OCCLUSION". NO OTHER DETAILS WERE AVAILABLE. THE BIOMED SUGGESTED THAT A TUBING CLAMP MAY HAVE BEEN MISSED, BUT REQUESTED THAT THE UNIT BE EVALUATED.

  Patient problems: Exsanguination; No Clinical Signs, Symptoms or Conditions

  MAUDE report 9603875 ↗
• MalfunctionDec 19, 2019Temperature Problem; Temperature Problem

  BELMONT'S SALES REPRESENTATIVE RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "ELECTRICAL CORD BURNT AND MELTED AT BASE OF MACHINE WHILE PLUGGED INTO OUTLET IN OR HALLWAY. SMOKE CAUSED FIRE ALARM AT 1857 ON (B)(6) 2019. RI-2 WAS FOUND SMOKING BY OR STAFF WHO UNPLUGGED THE DEVICE PRIOR TO FIRE DEPARTMENT RESPONSE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9492262 ↗
• MalfunctionOct 24, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE HOSPITAL BIOMED REPORTED THE FOLLOWING: "DURING A CASE ON (B)(6) 2019 THERE WAS A REPORT OF THE TOUCH SCREEN BEING FROZEN. SECTION OF THE TOUCH SCREEN DID NOT FUNCTION. THE USER REPOWERED THE UNIT BUT NOT ABLE TO RESOLVE THE ISSUE. THE HOSPITAL BIOMED WAS UNABLE TO CONFRIM THE ISSUE IN THE LAB."

  Patient problems: No Information

  MAUDE report 9236667 ↗
• MalfunctionSep 28, 2019Temperature Problem; Temperature Problem

  THE BIOMED AT THE USER FACILITY REPORTED THAT THE RAPID INFUSER "OVERHEATED" DURING A CASE.

  Patient problems: No Information

  MAUDE report 9132383 ↗
• MalfunctionAug 24, 2019Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A CASE, THERE WAS AN "OVERHEAT INCIDENT" AND THE DISPOSABLE SET HEAT EXCHANGER WAS DEFORMED. THE DISPOSABLE SET WAS DISCARDED DUE TO CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8928664 ↗
• MalfunctionAug 23, 2019Temperature Problem; Temperature Problem

  BELMONT'S CLINICAL SPECIALIST RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "DURING IN-SERVICE, AN ANESTHESIOLOGIST STATED THAT ONE OF THE BELMONT RAPID INFUSERS OVERHEATED IN THE PAST. ANESTHESIOLOGIST STATED HE REPLACED DISPOSABLE AND RESUMED INFUSION. PATIENT WAS UNHARMED AND DID NOT AFFECT CARE. THE ANESTHESIOLOGIST ALSO MENTIONED AFTER THE CASE THE BELMONT RAPID INFUSER WAS SENT TO BIOMED. BIOMED TESTED RAPID INFUSER AND OPERATED PROPERLY. RAPID INFUSER CURRENTLY BACK IN SERVICE. DISPOSABLES DISCARDED AND HOSPITAL UNABLE TO CONFIRM LOT NUMBERS OR SPECIFIC DEVICE SERIAL NUMBER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8927858 ↗
• MalfunctionJul 18, 2019Temperature Problem; Temperature Problem

  THE USER FACILITY REPORTED THAT THE OUTPUT TEMPERATURE OF THE RAPID INFUSER WAS DRIFTING BETWEEN 37.9 DEGREES CELSIUS AND 36.1 DEGREES CELSIUS AT A FLOW RATE OF 90ML/MIN. ANOTHER RAPID INFUSER WAS BROUGHT IN AND THE CASE WAS COMPLETED WITHOUT ANY ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8805754 ↗
• MalfunctionMay 30, 2019Mechanical Problem; Mechanical Problem

  INITIAL REPORT: IT WAS REPORTED THAT THE MOUNTING SCREW FOR THE PUMP ROLLER CAME LOOSE DURING A CASE. UPDATE: UPON FOLLOW UP, THE USER FACILITY STATED THAT THE ROLLER PUMP DISENGAGED DUE TO A MISSING SCREW AND THAT THEY WOULD LIKE TO RETURN THE UNIT FOR INVESTIGATION, AS THEY FELT THE THREADS MAY HAVE BEEN STRIPPED AND NEEDED A CLOSER LOOK. THE USER FACILITY REPORT (#6758990000-2019-0001) THAT WE RECEIVED FROM THE FDA STATED: "BELMONT RAPID INFUSER FAILED DURING CRITICAL NEED ON A PT IN THE ICU, IT WAS REPORTED THAT DURING USE, THE ROLLER DISENGAGED FROM THE RIVER SHAFT CAUSING UNIT FAILURE. PT EXPIRED. UNIT WAS SENT TO BIOMEDICAL ENGINEERING AND UPON VISUAL INSPECTION, IT WAS FOUND THAT THE UNIT'S ROLLER HEAD RETAINING SCREW WAS MISSING. UNIT WAS ISOLATED AND WILL BE SENT TO THE MFR FOR IN DEPTH INSPECTION."

  Patient problems: No Information

  MAUDE report 8656190 ↗
• MalfunctionMay 17, 2019Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THERE WAS AN OVERHEAT INCIDENT AFTER INFUSING FOR AROUND 7 HOURS. THE DISPOSABLE SET WAS DISCARDED. THE BIOMED CLEANED UP THE UNIT AND NOTICED A CRACK ON THE HEATER DISK.

  Patient problems: No Information

  MAUDE report 8621776 ↗
• MalfunctionMar 29, 2019Temperature Problem; Temperature Problem

  THE TRAUMA NURSE FROM THE USER FACILITY REPORTED THE FOLLOWING: "THE BELMONT MACHINE WAS TURNED ON AND THE TUBING PUT IN PLACE AND PRIMED. THE MACHINE WAS TURNED OFF AND A FEW MINUTES LATER THE MACHINE CAUGHT ON FIRE AND WAS PUT OUT BY THE STAFF WITH A FIRE EXTINGUISHER." IT WAS REPORTED THAT THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466861 ↗
• MalfunctionJan 25, 2019Power Problem; Power Problem

  THE USER FACILITY REPORTED THAT THE RAPID INFUSER LOST POWER DURING A CASE. ANOTHER UNIT WAS BROUGHT IN TO FINISH THE PROCEDURE AND THE PATIENT WAS NOT HARMED. THE BIOMED WAS UNABLE TO DUPLICATE THE FAILURE AFTER RUNNING THE UNIT NONSTOP FOR A FEW HOURS IN THE LAB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8279455 ↗
• MalfunctionJan 15, 2019Increase in Pressure; Increase in Pressure

  BELMONT'S CLINICAL SPECIALIST RECEIVED A COMPLAINT INVOLVING A BELMONT RAPID INFUSER AND REPORTED THE FOLLOWING: THE RAPID INFUSER WAS BEING USED ON A PATIENT IN THE ICU AND 2 UNITS OF BLOOD WERE INFUSED AT 45-60ML/MIN. THE FLOW RATE WAS SET TO 500ML/MIN AND KEPT ALARMING. THE FLOW RATE WAS DECREASED AND WHILE INFUSING THE THIRD UNIT OF BLOOD THE UNIT BEGAN EXHIBITING A "HIGH PRESSURE" ALARM AND STOPPED. THEY SWITCHED TO ANOTHER PUMP AND BEGAIN INFUSING BLOOD AT 999ML/HR (APPROXIMATELY 15ML/MIN). THE NURSE STATED THAT THE TRIPLE LUMEN THEY WERE USING WAS RATED BY THE MANUFACTURER FOR 10ML/HR AND NO OTHER LINE WAS USED. FURTHER DISCUSSION WITH THE CUSTOMER DETERMINED THAT THE CATHETER BEING USED AT THE TIME OF THE EVENT WAS A 7FR 3 LUMEN 20CM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8250342 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032674. One submission often covers many models, so check the product and lot details in each record.

• Z-0058-2013 · Sep 25, 2012 · Terminated
  Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.