Rapid Infuser RI-2, 120V, 1000ml/min 903-00037Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10896128002630), received between Nov 14, 2018 and Sep 23, 2026 — classified as 1 death, 1 injury, 74 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (12 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Smoking

  It was reported to Belmont that there was a smoking incident with the RI-2. Additional information was provided on 8/17 that the patient involved expired.

  Patient problems: Insufficient Information

  MAUDE report 50867693 ↗
• MalfunctionAug 26, 2026Air/Gas in Device

  Following an incident involving the patient sustaining a gun shot wound to the abdomen with an exit wound through the back. The patient was found by ACP on scene with Police and had seals placed to the abdomen and back. The patient was placed in the ambulance, assessed and transported. The patient arrived as a code trauma and an MHP was activated. The patient was diverted to the OR due to hemodynamic instability for a stat damage control laparotomy procedure. During priming of the Infuser - multiple air alarms were encountered and the device was not able to be used to the time sensitive nature of the MHP. In the end 2 cartridge systems were wasted and resuscitation was done manually with 5-6 hand pumped pressure bags and multiple staff supporting. The patient was stabilized in the OR and transferred to a level 1 trauma center for further management.

  Patient problems: Insufficient Information

  MAUDE report 50458090 ↗
• MalfunctionApr 11, 2026Smoking

  IT WAS REPORTED THAT DURING A LIVER TRANSPLANT PROCEDURE, THE PATIENT WAS ON AN ACTIVE MASSIVE TRANSFUSION PROTOCOL FOR MOST OF THE 10-12 HOUR CASE. THE BELMONT RAPID INFUSER WAS RUNNING AT 750 ML/HR FOR OVER 8 HOURS WHEN IT BEGAN TO EMIT SMOKE. THE DEVICE WAS IMMEDIATELY REPLACED AND SENT TO THE BIOMEDICAL TEAM FOR EVALUATION. THE ISSUE COULD NOT BE REPRODUCED. VISUAL INSPECTION IDENTIFIED SCORCHING OF THE HEATING COIL WITHIN THE DISPOSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851791 ↗
• MalfunctionMar 30, 2026Device Emits Odor; Smoking

  IT WAS REPORTED THAT DURING CLINICAL USE AS PART OF A MASSIVE TRANSFUSION PROTOCOL (MTP), THE DEVICE BEGAN EMITTING SMOKE. THE DEVICE WAS IMMEDIATELY REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720309 ↗
• MalfunctionMar 3, 2026Increase in Pressure

  IT WAS REPORTED THAT THE DEVICE WAS CONNECTED TO A CORDIS LINE AND INITIATED AT A FLOW RATE OF 50-75 ML/MIN WITHOUT ISSUE. WHEN THE INFUSION RATE WAS INCREASED ABOVE 75 ML/MIN TO FACILITATE RAPID BLOOD ADMINISTRATION, THE DEVICE DISPLAYED AN OVER PRESSURE ALARM. AT THE TIME, THE CORDIS LINE CONTAINED A CENTRAL LINE DELIVERING VASOPRESSORS AND FLUIDS THROUGH SEPARATE PORTS, AND A TRANSFUSION GUN WAS CONNECTED TO ONE OF THE CENTRAL LINE PORTS. DUE TO THE ALARM, A 16G EJ (EXTERNAL JUGULAR) PERIPHERAL IV WAS PLACED AND THE DEVICE WAS CONNECTED TO THAT LINE. HOWEVER, WHEN THE RATE WAS INCREASED TO APPROXIMATELY 200 ML/MIN, THE OVER PRESSURE ALARM RECURRED.

  Patient problems: Insufficient Information

  MAUDE report 24496540 ↗
• MalfunctionFeb 25, 2026Mechanical Problem

  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 24443502 ↗
• MalfunctionNov 5, 2025Flare or Flash; Flare or Flash

  IT WAS REPORTED THAT A FIRE OCCURRED AT THE BACK OF THE RI-2 UNIT AT THE AC POWER ENTRY LOCATION. THERE WAS NO PATIENT INVOLVEMENT AND THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475710 ↗
• MalfunctionSep 17, 2025Pressure Problem; Pressure Problem

  THE MEDSUN REPORT STATED THAT DURING A MASSIVE TRANSFUSION PROTOCOL, THE BELMONT RAPID INFUSER EXHIBITED REPEATED "HIGH PRESSURE" ALARMS. TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING REPOSITIONING THE TUBING, SWITCHING IV ACCESS SITES, REPLACING THE DISPOSABLE SET, AND SUBSTITUTING THE DEVICE WITH ANOTHER BELMONT UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072096 ↗
• MalfunctionAug 13, 2025Smoking; Smoking

  RAPID TRANSFUSER (BELMONT) REF # 903-00037; SMOKING DURING TRANSFUSION AT 500CC/MIN X 40 + MIN.

  Patient problems: Insufficient Information

  MAUDE report 22798504 ↗
• MalfunctionAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  TWO BELMONT MACHINES MALFUNCTIONED - UNABLE TO DELIVER BLOOD ON A TRAUMA PATIENT BROUGHT BACK FOR A RETURN TO OR 1 - BELMONT MALFUNCTIONED - HAD TO WAIT AND TURN OFF FOR RESET - HAD TO USE VASOPRESSORS FOR BP MAINTENANCE RATHER THAN BLOOD DUE TO MALFUNCTION.

  Patient problems: Hypovolemia; Low Blood Pressure/ Hypotension

  MAUDE report 22798502 ↗
• MalfunctionAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  BELMONT WITH MULTIPLE FAILURES PREVENTING RAPID ADMINISTRATION OF BLOOD PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798437 ↗
• MalfunctionAug 13, 2025Overheating of Device; Air/Gas in Device; Overheating of Device; Air/Gas in Device

  TWO BELMONT MACHINE FAILURE - ON A TRAUMA - WOULD NOT DELIVER THE BLOOD, SAID AIR IN LINE THEN OVER HEATED.

  Patient problems: Insufficient Information

  MAUDE report 22798432 ↗
• MalfunctionAug 13, 2025Overheating of Device; Air/Gas in Device; Overheating of Device; Air/Gas in Device

  TWO BELMONT MACHINE FAILURE - ON A TRAUMA - WOULD NOT DELIVER THE BLOOD, SAID AIR IN LINE THEN OVER HEATED.

  Patient problems: Insufficient Information

  MAUDE report 22798421 ↗
• MalfunctionAug 13, 2025Power Problem; Power Problem

  TWO BELMONT MACHINES FAILED IN MASS TRANSFUSION EVENT, FIRST BELMONT SMOKED AND RAN OVER TEMP. BELMONT # 2 WOULD NOT TURN ON WHEN REPLACING OVER TEMP BELMONT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798415 ↗
• MalfunctionAug 13, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  DURING A LIVER TRANSPLANT, TWO BELMONT MACHINES MALFUNCTIONED, THE SECOND BELMONT MALFUNCTIONING WHILE THE PATIENT WAS ANHEPATIC. OVERHEATED/SMOKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798213 ↗
• MalfunctionAug 13, 2025Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  TWO BELMONT MACHINES FAILED IN MASS TRANSFUSION EVENT FIRST BELMONT SMOKED AND RAN OVER TEMP. BELMONT # 2 WOULD NOT TURN ON WHEN REPLACING OVER TEMP BELMONT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798014 ↗
• MalfunctionAug 8, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  DURING A LIVER TRANSPLANT, TWO BELMONT MACHINES MALFUNCTIONED, THE SECOND BELMONT MALFUNCTIONING WHILE THE PATIENT WAS ANHEPATIC. OVERHEATED/SMOKE. REFERENCE REPORT: MW5172003. PT CODE: 4582. DEVICE CODES: 1585, 1437.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755417 ↗
• MalfunctionJul 2, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT, "REGISTERED NURSE (RN) WAS CALLED INTO TRAUMA TO SET UP BELMONT RAPID INFUSER (MODEL RAPID INFUSER RI-2). FIRST SET OF TUBING HAD A MANUFACTURING ERROR AND WAS "TWISTED" AND COULD NOT BE CONNECTED INTO BELMONT. SAME ISSUE OCCURRED WITH SECOND SET OF TUBING. THIRD SET OF TUBING WAS ABLE TO BE CONNECTED INTO BELMONT, BUT AFTER PRIMING THE TUBING, THE MACHINE KEPT REPORTING A SYSTEM ERROR FOR TEMPERATURE. RN THEN TOOK SECOND BELMONT MACHINE, CONNECTED NEW TUBING, AND PRIMED THE LINE. RN THEN CONNECTED TUBING TO THE PATIENT, AND BELMONT REPORTED A SYSTEM ERROR STATING THAT THE PRESSURE WAS TOO HIGH. RN CHECK FOR ANY CLAMPED LINES, AND FOR PATENCY OF THE LINE. THERE WERE NO CLAMPS AND LINE WAS PATENT. BELMONT KEPT STATING A SYSTEM ERROR FOR PRESSURE SO RN SWITCHED FLUIDS AND BLOOD TO THE ALARIS PUMP PER MD ORDERS".

  Patient problems: Insufficient Information

  MAUDE report 22391703 ↗
• MalfunctionJul 2, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT, "REGISTERED NURSE (RN) WAS CALLED INTO TRAUMA TO SET UP BELMONT RAPID INFUSER (MODEL RAPID INFUSER RI-2). FIRST SET OF TUBING HAD A MANUFACTURING ERROR AND WAS "TWISTED" AND COULD NOT BE CONNECTED INTO BELMONT. SAME ISSUE OCCURRED WITH SECOND SET OF TUBING. THIRD SET OF TUBING WAS ABLE TO BE CONNECTED INTO BELMONT, BUT AFTER PRIMING THE TUBING, THE MACHINE KEPT REPORTING A SYSTEM ERROR FOR TEMPERATURE. RN THEN TOOK SECOND BELMONT MACHINE, CONNECTED NEW TUBING, AND PRIMED THE LINE. RN THEN CONNECTED TUBING TO THE PATIENT, AND BELMONT REPORTED A SYSTEM ERROR STATING THAT THE PRESSURE WAS TOO HIGH. RN CHECK FOR ANY CLAMPED LINES, AND FOR PATENCY OF THE LINE. THERE WERE NO CLAMPS AND LINE WAS PATENT. BELMONT KEPT STATING A SYSTEM ERROR FOR PRESSURE SO RN SWITCHED FLUIDS AND BLOOD TO THE ALARIS PUMP PER MD ORDERS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391694 ↗
• MalfunctionJun 24, 2025Crack; Device Emits Odor; Crack; Device Emits Odor

  THE RI-2 WAS INFUSING AT 500 ML/MIN WHEN THE USERS NOTICED BLOOD SPLITTING FROM THE CLOSED DOOR. TRANSFUSION WAS STOPPED. PHOTOS WERE TAKEN. TUBING LOOKS TO BE CRACKED AND IT SMELT LIKE BURNT RUBBER.

  Patient problems: Insufficient Information

  MAUDE report 22319449 ↗
• MalfunctionJun 3, 2025Temperature Problem; Temperature Problem

  THE BIOMED REPORTED THAT, THE UNIT WAS HAVING ERROR 102 DURING OVER TEMP INCIDENT WITH THE PATIENT DURING A CASE. THERE IS NO DETAILS EXCEPT FOR THE PATIENT PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 22131799 ↗
• InjuryMar 6, 2025Air/Gas in Device; Air/Gas in Device

  THE BIOMED REPORTED THAT, "BELMONT RAPID INFUSER RI-2 HAVING, SN: (B)(6), REF 903-00039 RECENTLY HAD AN ISSUE WHERE A LINE INTO THE RESERVOIR CLOTTED OFF. WHEN THE INTAKE CLOTTED OFF, A SIGNIFICANT AMOUNT OF AIR WAS ENTRAINED INTO THE SYSTEM. IT WAS NOT CAUGHT BY THE AIR SENSOR AND MADE IT INTO THE PATIENT LINE. THE MACHINE WAS STOPPED PRIOR TO IT GOING TO THE PATIENT. THE AIR WAS REMOVED BY HAND AND THE MACHINE OPERATED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536172 ↗
• MalfunctionFeb 26, 2025Complete Loss of Power; Complete Loss of Power

  THE MEDWATCH REPORT #MW5164621 STATED THAT, BELMONT BLOOD INFUSER SUDDENLY LOST POWER IN THE MIDDLE OF A MASSIVE TRANSFUSION. UNABLE TO GET MACHINE TO TURN BACK ON. HAD TO BORROW ANOTHER BELMONT MACHINE FROM ER TO CONTINUE MASSIVE TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469213 ↗
• MalfunctionOct 18, 2024Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE MEDSUN REPORT STATES THE FOLLOWING, THE BELMONT OVERHEATED DURING USE AND WAS NONFUNCTIONAL; WOULD ONLY TRANSFUSE AT 50ML/MIN, FOR ONE MINUTE, AND SHUT DOWN GIVING AND OVERHEATING ERROR. PATIENT UNDERWENT PLANNED RIGHT RATS LOWER LOBECTOMY WITH MEDIASTINAL LYMPH NODE DISSECTION AND INTERCOSTAL BLOCKS IN THE MORNING OF [REDACTED]. HE EXTUBATED AND WENT TO THE RECOVERY ROOM FOR ABOUT TWO HOURS. AT THAT TIME THE PATIENT RAPIDLY DUMPED 900CC OF BLOOD INTO HIS CHEST TUBES THE PATIENT WAS TAKEN BACK TO THE OR, INTUBATED WITH A DOUBLE LUMEN TUBE, PREPPED AND DRAPED. HE UNDERWENT AN ANTEROLATERAL MUSCLE SPARING THORACOTOMY. POST-OP HEMORRHAGE RESULTING IN HEMORRHAGIC SHOCK AND EXPIRATION.

  Patient problems: Insufficient Information

  MAUDE report 20487347 ↗
• MalfunctionOct 18, 2024Calibration Problem; Calibration Problem

  THE BIOMED REPORTED THAT I TRIED TO SET UP THE FBU BELMONT IN PREPARATION FOR A SUSPECTED UTERINE RUPTURE. IT WAS NOT BOOTING PROPERLY. I HAD TO BORROW FROM MAIN OR. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 20481008 ↗

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