Rapid Infuser RI-2, 120V, 750 ml/min 903-00039Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 10896128002760), received between Aug 7, 2017 and May 1, 2026 — classified as 1 injury, 131 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (26 reports).

2 other recalls cover devices cleared under the same FDA submission (K242735); 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 132 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Overheating of Device

  IT WAS REPORTED THAT DURING USE ON AN UNSTABLE TRAUMA PATIENT IN THE OPERATING ROOM, AN ATTEMPT WAS MADE TO INITIATE RAPID TRANSFUSION USING THE BELMONT DEVICE. THE UNIT BRIEFLY OPERATED, AND WAS INVOLVED IN A OVERHEATING INCIDENT, WITH SMOKE OBSERVED ORIGINATING FROM THE DISPOSABLE SET AND THEN SHUT DOWN. ATTEMPTS TO RESTART THE UNIT WERE UNSUCCESSFUL. A DIFFERENT RI-2 UNIT AND A NEW DISPOSABLE SET WERE USED TO COMPLETE THE CASE. NO PATIENT HARM WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25058229 ↗
• MalfunctionMar 12, 2026Power Problem

  IT WAS REPORTED THAT THE UNIT LOST POWER IN THE MIDDLE OF THE CASE AND SHUT OFF IMMEDIATELY. NO OTHER DETAILS WERE PROVIDED EXCEPT THAT THE PATIENT PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 24578696 ↗
• MalfunctionFeb 2, 2026

  BELMONT TUBING CHANNEL (DIVERTER VALVE) LOCKED IN ONE POSITION THEREFORE NOT ALLOWING THE RN TO LOAD THE TUBING PROPERLY. THE BELMONT UNIT HAD TO BE SWAPPED OUT FOR ANOTHER UNIT CREATING A DELAY IN PATIENT CARE FOR AN EMERGENT TRAUMA PATIENT WHO REQUIRED BLOOD PRODUCTS. THERE IS NO KNOWN HARM TO THE PATIENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229702 ↗
• MalfunctionJan 7, 2026Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING A MASSIVE TRANSFUSION PROTOCOL (MTP), APPROXIMATELY 5-10 MINUTES INTO RAPID BLOOD TRANSFUSION, THE DEVICE BEGAN EMITTING SMOKE AND THE DISPOSABLE SET WAS OBSERVED TO BE MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993283 ↗
• MalfunctionOct 31, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A CASE IN WHICH BELMONT RI-2 WAS BEING USED FOR A MASSIVE TRANSFUSION, THE UNIT EXPERIENCED AN OVERHEATING INCIDENT AND EXHIBITED ERROR 102, RESULTING IN THE DELAY IN TRANSFUSION. A SECOND UNIT WAS BROUGHT IN TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437655 ↗
• MalfunctionOct 22, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE UNIT WAS CONSTANTLY EXHIBITING ERROR 101. ALL SENSORS WERE CLEANED AND A NEW DISPOSABLE WAS INSTALLED, HOWEVER, THE ERROR PERSISTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359055 ↗
• MalfunctionAug 8, 2025Smoking; Smoking

  IT WAS REPORTED THAT, "THE DEVICE HAD FAILED WHILE BEING USED ON A PATIENT. THE STAFF STATED THAT THE DEVICE STARTED TO SMOKE, BUT THE PATIENT WAS NOT HARMED OR INJURED WHEN THE FAILURE OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755014 ↗
• MalfunctionMay 29, 2025Excessive Heating; Air/Gas in Device; Excessive Heating; Air/Gas in Device

  THE NURSE MANAGER REPORTED THAT THE DISPOSABLE TUBING BURST WITH BLOOD INSIDE THE UNIT DURING A PROCEDURE. THE PATIENT EXPERIENCED AN AIR EMBOLISM. THE UNIT HAS SINCE BEEN CLEANED UP. ACCORDING TO THE USERS, THERE WERE TWO DISPOSABLE SETS INVOLVED. THE 1ST SET WAS INSTALLED BUT EXPERIENCING HIGH PRESSURE (AT THE TIME OF PRIMING). THE 2ND SET WAS USED FOR THE CASE AND WAS BURSTING.

  Patient problems: Insufficient Information

  MAUDE report 22109415 ↗
• MalfunctionMar 21, 2025Complete Loss of Power; Complete Loss of Power

  THE USERS REPORTED THAT THE UNIT SHUT DOWN DURING A PROCEDURE. NO DETAILS IS AVAILABLE. DUE TO THE PATIENT INVOLVEMENT, THE UNIT IS UNDER RISK MANAGEMENT CONTROL.

  Patient problems: Insufficient Information

  MAUDE report 21665263 ↗
• MalfunctionDec 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER BELMONT'S CLINICAL SPECIALIST- (B)(6)"NOTES: SPOKE WITH USER FACILITY'S BIOMED (B)(6) AND HE EXPLAINED THE PATIENT ABDOMEN WAS FILLING UP WITH BLOOD DURING TRANSFUSION. HE GAVE 3 UNITS OF PRBC'S AND 2 UNITS OF FFP. WHEN HE WAS ABOUT TO GIVE THE 4TH UNIT OF PRBC'S THE RI-2 STOPPED AND GAVE THE ERROR CODE. BIOMED WAS ALSO ON THE CALL AND HE RAN THE UNIT AND WAS NOT GETTING ANY ERROR CODE AND ASKED IF THE RI-2 CAN BE PUT BACK INTO CIRCULATION. I TOLD HIM TO BE ON THE SAFE SIDE TO GO AHEAD AND SHIP THE UNIT BACK TO GET CHECKED OUT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021020 ↗
• MalfunctionDec 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY STAFF REPORTED THAT, UNKNOWN IF IT WAS BELMONT C81287 OR C80903. BELMONT WAS PRIMED WITHOUT DIFFICULTY. WHEN ATTEMPTING TO INFUSE BLOOD AN ERROR STATING THERE WAS AIR IN THE CHAMBER KEPT ALARMING. ATTEMPTED TO SQUEEZE THE CHAMBER MULTIPLE TIMES TO CORRECT BUT KEPT RECEIVING THE SAME ERROR MESSAGE. WAS ABLE TO TURN OFF/ON AND RE-PRIME WITHOUT DIFFICULTY. NO AIR WAS SEEN /DETECTED BY THIS REGISTERED NURSE (RN) OR OTHER RNS INVOLVED. HAD TO HAND PUMP BLOOD INTO THE PATIENT USING BLOOD TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897304 ↗
• MalfunctionNov 19, 2024Overheating of Device; Overheating of Device

  THE BIOMED RECEIVED A REPORT FROM THE USERS THAT THERE WAS AN OVER HEAT INCIDENT DURING A CASE MORE THAN 3 WEEKS AGO. THE PATIENT WAS NOT HARMED. THERE IS NO DETAILS EXCEPT THAT THE PATIENT WAS NOT HARMED. THE BIOMED PERFORMS A FULL FUNCTIONAL TEST AND IS UNABLE TO CONFIRM ANY ISSUE WITH A KNOWN GOOD DISPOSABLE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730336 ↗
• MalfunctionOct 31, 2024Pressure Problem; Pressure Problem

  THE BIOMED REPORTED THAT THE UNIT WAS HAVING HIGH PRESSURE ALARM DURING A CASE WITH THE PATIENT INVOLVED. THE DISPOSABLE SET WAS REPLACED WITH A NEW ONE BUT HIGH-PRESSURE ALARM STILL PERSISTS. THE PATIENT PASSED AWAY DURING THE INCIDENT. ALTHOUGH THE PATIENT INVOLVED IN THE INCIDENT EXPIRED, IT WAS CONFIRMED THAT THE DEVICE DID NOT CAUSED OR CONTRIBUTED TO THE DEATH. THE UNIT IS NOW UNDER QUARANTINE WITH THE USER IN RISK MANAGEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20582058 ↗
• MalfunctionOct 29, 2024Infusion or Flow Problem; Temperature Problem; Infusion or Flow Problem; Temperature Problem

  THE USER FACILITY REPORTED THAT, "UNIT WAS EXPERIENCING OVER TEMPERATURE INCIDENT DURING A CASE. ANOTHER RI-2 WAS BROUGHT IN TO USE BUT THE PATIENT DIED. THE STAFFS BELIEVE THE PATIENT DIED DUE TO THE INJURIES. THE DISPOSABLE SET WAS DISCARDED AND NO LOT# IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20561061 ↗
• MalfunctionOct 18, 2024Failure to Power Up; Failure to Power Up

  THE USER FACILITY REPORTED THAT PROFUSE BLEEDING IN OR DURING PROCEDURE, NEEDED TO USE BELMONT TRANSFUSER. DEVICE WOULD NOT TURN ON AT ALL, WAS PLUGGED IN.

  Patient problems: Insufficient Information

  MAUDE report 20481873 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Device Emits Odor; Temperature Problem; Fluid/Blood Leak; Device Emits Odor; Temperature Problem

  ON JULY 23RD, 2024, BELMONT RECEIVED MEDWATCH REFERENCE NUMBER (B)(4) DETAILING AN INCIDENT THAT OCCURED ON MAY 25TH, 2024. THE MEDWATCH REPORT STATED THAT DURING MTP (MASSIVE TRANSFUSION PROTOCOL) THE BELMONT HEATING ELEMENT/FILTER BURNED THROUGH AND STARTED LEAKING BLOOD ONTO THE FLOOR. THIS WAS AT OR ABOUT BLOOD PRODUCT NUMBER 32. THERE WAS A BLACKENED AREA TO THE RING. ELECTRICAL BURNING SMELL WAS ALSO PRESENT. THE BELMONT RAPID TRANSFUSER WAS FOUND TO HAVE NO MALFUNCTION. TUBING MALFUNCTION SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036741 ↗
• MalfunctionAug 13, 2024Temperature Problem; Temperature Problem

  THE USER FACILITY'S BIOMED RECEIVED THE REPORT FROM THE USERS THAT THERE WAS AN INCIDENT OF TEMPERATURE ALARM DURING A CASE ON (B)(6) 2024. NO DETAILS EXCEPT THAT THE PATIENT PASSED AWAY. THE RISK MANAGER QUARANTINED THE DEVICE FOR A THIRD PARTY INVESTIGATION. ALTHOUGH PATIENT INVOLVED IN THE INCIDENT EXPIRED, THERE ARE NO ALLEGATIONS THAT THE DEVICE CAUSED OR CONTRIBUTED TO DEATH.

  Patient problems: Insufficient Information

  MAUDE report 19977439 ↗
• MalfunctionJul 10, 2024Complete Loss of Power; Complete Loss of Power

  ON 11 JUNE 2024, BELMONT MEDICAL TECHNOLOGIES RECEIVED MEDWATCH REFERENCE NUMBER (B)(4) DETAILING AN INCIDENT THAT OCCURRED ON (B)(6) 2024. THE USER FACILITY REPORT BY (B)(6) STATES FOLLOWING: PATIENT CAME IN TO EMERGENCY DEPARTMENT (ED) WITH MULTIPLE GUNSHOT WOUNDS TO TORSO. MASSIVE TRANSFUSION PROTOCOL WAS STARTED USING BELMONT RAPID INFUSER. PATIENT TAKEN TO OPERATING ROOM FOR EXPLORATORY LAPAROSCOPY. DURING THE 4TH ROUND OF MEDIA TRANSFER PROTOCOL (MTP) ADMINISTRATION, THE PRIMARY OR BELMONT UNEXPECTEDLY SHUT DOWN WITHOUT WARNING. A MEMBER OF THE OR TEAM RAN TO RETRIEVE THE BELMONT FROM THE CARDIOVASCULAR OPERATING ROOM (CVOR). ONCE THE CVOR BELMONT ARRIVED, IT WAS SET UP, BUT THEN THEY REALIZED IT WAS ALSO MALFUNCTIONING - IT WAS UNABLE TO HEAT THE BLOOD, AND IT RESTRICTED THE ADMINISTRATION SPEED TO 50CC/HOUR. THE PATIENT WAS EXPERIENCING SUBSTANTIAL BLOOD LOSS AND OCCASIONAL HEMODYNAMIC INSTABILITY, SO THEY THEN CONTACTED THE ED TO HAVE THEM BRING A BELMONT FROM THE ED UP TO THE OR FOR THEM TO USE. THE BELMONT THEY GOT FROM THE ED DID NOT MALFUNCTION AND ALLOWED THE TEAM TO GIVE TWO MORE ROUNDS OF MTP. THE PATIENT HAS RECOVERED, ALTHOUGH HE HAS ENDED UP WITH A COLOSTOMY. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709893 ↗
• MalfunctionJul 8, 2024Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMED REPORTED THAT THERE WAS AN OVERHEAT INCIDENT DURING A CASE WITH THE PATIENT INVOLVED. THERE IS FEW DETAIL BUT THE BIOMED PROMISED TO GATHER ADDITIONAL INFORMATION. THE OVERHEAT INCIDENT OCCURRED AFTER 20 UNITS OF WHOLE BLOOD WERE DELIVERED TO THE PATIENT. ALTHOUGH PATIENT INVOLVED IN THE INCIDENT EXPIRED, THE USER FACILITY CONFIRMED THAT THIS WAS DUE TO SEVERE GUN-SHOT WOUND.

  Patient problems: Insufficient Information

  MAUDE report 19698257 ↗
• MalfunctionJun 5, 2024Complete Loss of Power; Complete Loss of Power

  THE BIOMED REPORTED THAT DURING A CASE WITH MASS TRANSFUSION ON (B)(6) 2024, THE UNIT SHUT DOWN WITH NO WARNING MESSAGE. THE PATIENT PASSED AWAY DUE TO SERIOUS INJURY AND THE STAFFS DO NOT BELIEVE THE RI-2 WAS A CONTRIBUTING FACTOR. THE UNIT HAS SINCE BEEN IN ISOLATION IN THE BIOMED SHOP. THE STAFF REQUESTED TO SEND THE UNIT BACK FOR A COMPLETED CHECKOUT.

  Patient problems: Insufficient Information

  MAUDE report 19473948 ↗
• MalfunctionMar 7, 2024Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating

  THE USER FACILITY REPORTED TO THE BELMONT'S CLINICAL SPECIALIST THAT THE RI-2 GENERATED AN ERROR 102 DURING A PROCEDURE. IT WAS REPORTED THE PATIENT INVOLVED EXPIRED, HOWEVER THE DEVICE WAS NOT A CONTRIBUTING FACTOR.

  Patient problems: Insufficient Information

  MAUDE report 18862949 ↗
• MalfunctionSep 22, 2023Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT DURING AN EDUCATIONAL TRAINING, IT IS ALLEGED THAT THE DEVICE CAUGHT FIRE AT THE BACK OF THE UNIT WHERE THE POWER CORD IS PLUGGED IN. THERE WERE SIGNS OF FLUID LEAKING, BUT THE STAFF WAS UNCERTAIN WHERE FROM. ON AUGUST 31ST, THE USER FACILITY CONFIRMED THAT THERE WAS NO LEAKING FROM THE DISPOSABLE SET. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT SINCE THE EVENT OCCURRED DURING TRAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17802878 ↗
• MalfunctionAug 31, 2022Smoking; Flare or Flash; Smoking; Flare or Flash

  THE BIOMED REPORTED THAT THERE WERE FLAMES, SMOKE AND MELTING NEAR THE AC POWER CORD OF THE RI-2. THERE IS NO PATIENT INVOLVEMENT IN THE EVENT AND THE SYSTEM WAS NOT USED IN THE PROCEDURE. THE BELMONT'S CLINICAL SPECIALIST CONFIRMED THAT THE EVENT OCCURED PRIOR TO BEING PUT IN USE ON A PATIENT. IT IS SUSPECTED THAT THE MOST LIKELY CAUSE FOR THE INCIDENT WOULD INDICATE CRYSTALLOID SOLUTIONS (NA+ & CL-) ENCOUNTERING THE POWER SOURCE ON THE BACK OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331301 ↗
• MalfunctionMar 22, 2022Thermal Decomposition of Device; Device Emits Odor; Protective Measures Problem

  BELMONT INFUSER BEING USED FOR MASSIVE TRANSFUSION, WHEN SMOKE SMELL NOTED AND MACHINE BEEPING. TUBING NOTED TO BE SCORCHED WHEN REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 13844676 ↗
• MalfunctionFeb 8, 2022Excessive Heating; Excessive Heating

  THE USER FACILITY REPORTED THE FOLLOWING INCIDENT INVOLVING A BELMONT RAPID INFUSER, RI-2: "THE BELMONT MACHINE WAS ON A PATIENT THAT WE CODED FOR 2.5 HOURS. THERE WAS AN ERROR CODE OF EITHER 102 OR 104. IT SAID THE PRIMATE WAS TOO HOT AND REMOVE FROM SERVICE. WE TURNED IT OFF AND BACK ON WITH THE SAME ERROR CODE. IT SAID SOMETHING LIKE TO PRIME A NEW SET. THE PATIENT EXPIRED BEFORE I COULD PRIME ANOTHER LINE."

  Patient problems: Insufficient Information

  MAUDE report 13486185 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K242735. One submission often covers many models, so check the product and lot details in each record.

• Z-1678-2025 · Mar 31, 2025 · Open, Classified
  3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (
• Z-1099-2025 · Jan 2, 2025 · Open, Classified
  Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warm