UK, Rapid Infuser RI-2, 230V, 750 ml/min 903-00039A-UKRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00896128002817), received between Nov 21, 2018 and May 7, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (4 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, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Power Problem

  IT WAS REPORTED THAT, DESPITE BEING PLUGGED INTO AC POWER, THE DEVICE WOULD NOT DELIVER FLUID AT A RATE ABOVE 50 ML/MIN AND DID NOT PROVIDE HEATING. THE DISPLAY INDICATED "BATTERY, NO HEATING." THE USER CONFIRMED MULTIPLE TIMES THAT THE UNIT WAS PROPERLY CONNECTED TO AC POWER. IT WAS ALSO REPORTED THAT ON A SEPARATE OCCASION, THERE WAS DIFFICULTY INITIATING OPERATION OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112637 ↗
• MalfunctionAug 18, 2023Device Emits Odor; Device Emits Odor

  BELMONT RECEIVED MHRA REPORT (B)(4) WHICH DETAILED THE FOLLOWING. THE DEVICE WAS ATTACHED TO A PATIENT IN THE EVENT OF A CATASTROPHIC BLOOD LOSS. MOMENTS AFTER THE DEVICE STARTED RUNNING THERE WAS A STRONG BURNING SMELL WITNESSED BY ALL MEMBERS OF THE TEAM. AREA INSPECTED AND CONFIRMED THAT IT WAS THE BELMONT RI2. DEVICE STOPPED AND REMOVED FROM SERVICE IMMEDIATELY. PRESSURE INFUSION BAGS UTILISED TO CONTINUE THE TREATMENT. IT WAS REPORTED THE PATIENT EXPIRED DURING THE EVENT, ALTHOUGH THE DEVICE WAS NOT A CONTRIBUTING FACTOR.

  Patient problems: Insufficient Information

  MAUDE report 17572172 ↗
• MalfunctionAug 10, 2023Improper Flow or Infusion; Improper Flow or Infusion

  BELMONT RECEIVED THE FOLLOWING REPORT VIA MIR 2023/007/012/501/006. SET UP ORIGINALLY FOR THE CASE WORKING FINE. MACHINE THEN CAME UP WITH AIR IN GIVING SET. TRIED TO RECTIFY MULTIPLE TIMES, CHANGING THE CONSUMABLES. MACHINE THEN CAME UP WITH SERVICE ERROR EVERY TIME AFTER WE HAD PRIMED THE LINE, NO ALARM PRESENT WHEN THIS HAPPENED. YET WHILST IT WAS SAYING SERVICE ERROR AND NOT ALLOWING US TO INFUSE, THE VOLUME OF FLUID WHICH GOES INTO THE PATIENT WAS INCREASING RAPIDLY ON THE MACHINE, IT GOT TO AROUND 6000L (SAYING THATS WHAT WE HAD USED AND WAS CONTINUOUSLY GOING UP) DESPITE IT NOT INFUSING, WE KNOW THIS AS IT WASNT CONNECTED TO THE PATIENT. THE MACHINE TOUCH SCREEN THEN FAILED AND WOULD NOT WORK. WE TURNED THE MACHINE OFF FOR A WHILE AND LATER TRIED AGAIN IN THE EVENING TO SEE IF THIS PROBLEM HAD RECTIFIED AND IT WAS STILL DOING THE SAME.

  Patient problems: Insufficient Information

  MAUDE report 17506244 ↗
• MalfunctionMay 12, 2022Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating

  BELMONT RAPID INFUSER, RI-2 WAS CORRECTLY SETUP ON MAINS POWER, PLUGGED IN, INSERT PLACED INTO POSITION CORRECTLY, RAN 500ML SODIUM CHLORIDE THROUGH TO PRIME. NO CONCERNS USED APPROX 6 RBC + 6 FFP FOR BETWEEN 1 - 1.5 HOURS INTO PATIENT WITH NO ISSUES. AT THE 1 HOUR - 1.5 HOUR POINT BELMONT ALARMS WITH: 'SYSTEM ERROR #101 CHECK TEMPERATURE PROBES FOR BLOCKAGE. CLEAN WINDOWS. PRESS RETRY TO CONTINUE. SERVICE MACHINE IF ERROR PERSISTS.' RETRIED, BLOOD ML/MIN SET AT 140ML/MIN, ERROR OCCURRED EVERY 15-30 SECONDS. CHANGED PLUG SOCKET TO SEE IF THIS RESOLVED THE HEATING ISSUE. ERROR STILL OCCURRED. HAD TO RUN REMAINING BLOOD THROUGH TO BELOW HEATING LEVEL (BELOW 50ML/MIN) TO NOT WASTE PRODUCTS. THE CUSTOMER LATER INFORMED THAT THE PATIENT PASSED AWAY BUT, IT WASN'T DUE TO THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 14385407 ↗
• MalfunctionMay 11, 2022Expulsion; Expulsion

  DURING AN EMERGENCY ANEURISM CASE THE BELMONT DISPLAYED AN ERROR CODE AND WAS REMOVED AND REPLACED BY THE LEVEL 1 TO CONTINUE CASE. PATIENT LATER DIED ON TABLE BUT THE BELMONT WAS NOT BLAMED IN ANY WAY FOR THE OUTCOME OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 14354703 ↗
• MalfunctionFeb 24, 2022Insufficient Heating; Insufficient Heating

  BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING REPORT (INCIDENT NUMBER (B)(4)) FROM THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) IN THE (B)(6): "WHILE USING THE RI-2, THERE WAS A PROBLEM WITH THE HEATING ELEMENT AND WE WERE UNABLE TO TRANSFUSE THE VOLUME REQUIRED QUICKLY ENOUGH. WE THEN GOT A SECOND RAPID INFUSER TO RECTIFY THE PROBLEM AND THE SAME THING HAPPENED AGAIN. WE ENDED UP USING BOTH SIMULTANEOUSLY AS NONE OF THE TWO WAS ABLE TO DELIVER THE BLOOD PRODUCTS QUICKLY ENOUGH AND THIS WAS SUB-OPTIMAL. THERE WERE ALARMS AND AN ERROR MESSAGE DISPLAYED ON THE SCREEN EVERY 15-20 SECONDS REGARDING A HEATING PROBLEM. IT WAS TRANSFUSING AT A RATE OF 500MLS/MIN FOR A FEW SECONDS THEN IT WOULD STOP AS THE TEMPERATURE WAS DISPLAYED AS 32C. BOTH RAPID INFUSERS WERE RUNNING ON MAINS ELECTRICAL POWER FOR THE WHOLE TIME." TWO RI-2 UNITS WERE INVOLVED IN THIS INCIDENT: SERIAL NUMBERS (B)(4). THIS REPORT IS RELATED TO (B)(4); A SEPARATE REPORT WILL BE SUBMITTED FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595124 ↗
• MalfunctionFeb 24, 2022Insufficient Heating; Insufficient Heating

  BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING REPORT (INCIDENT NUMBER (B)(4)) FROM THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) IN THE (B)(6): "WHILE USING THE RI-2, THERE WAS A PROBLEM WITH THE HEATING ELEMENT AND WE WERE UNABLE TO TRANSFUSE THE VOLUME REQUIRED QUICKLY ENOUGH. WE THEN GOT A SECOND RAPID INFUSER TO RECTIFY THE PROBLEM AND THE SAME THING HAPPENED AGAIN. WE ENDED UP USING BOTH SIMULTANEOUSLY AS NONE OF THE TWO WAS ABLE TO DELIVER THE BLOOD PRODUCTS QUICKLY ENOUGH AND THIS WAS SUB-OPTIMAL. THERE WERE ALARMS AND AN ERROR MESSAGE DISPLAYED ON THE SCREEN EVERY 15-20 SECONDS REGARDING A HEATING PROBLEM. IT WAS TRANSFUSING AT A RATE OF 500MLS/MIN FOR A FEW SECONDS THEN IT WOULD STOP AS THE TEMPERATURE WAS DISPLAYED AS 32C. BOTH RAPID INFUSERS WERE RUNNING ON MAINS ELECTRICAL POWER FOR THE WHOLE TIME." TWO RI-2 UNITS WERE INVOLVED IN THIS INCIDENT: SERIAL NUMBERS (B)(4). THIS REPORT IS RELATED TO (B)(4); A SEPARATE REPORT WILL BE SUBMITTED FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595103 ↗
• MalfunctionFeb 11, 2022Insufficient Heating; Insufficient Heating

  BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING REPORT (INCIDENT NUMBER (B)(4)) FROM THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) IN THE (B)(6): "BELMONT RI-2 DEVICE STOPPED WORKING AND DISPLAYED ERROR MESSAGE 'CHECK TEMPERATURE PROBES FOR BLOCKAGE. CLEAN WINDOWS. PRESS RETRY TO CONTINUE. SERVICE MACHINE IF ERROR PERSISTS.'"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518342 ↗
• MalfunctionJan 17, 2022Electrical /Electronic Property Problem; Electrical Overstress; Electrical /Electronic Property Problem; Electrical Overstress

  BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING REPORT (INCIDENT NUMBER (B)(4)) FROM (B)(6) IN THE UK: "DEVICE TRIPPED OUT THE MAINS AC CONTACT BREAKER IN EMERGENCY OPERATING THEATRE." IT WAS REPORTED THAT THE INCIDENT OCCURRED DURING ROUTINE TESTS IN THE WORKSHOP WITH NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13269080 ↗
• MalfunctionNov 7, 2021Restricted Flow rate; Insufficient Heating; Overheating of Device; Restricted Flow rate; Insufficient Heating; Overheating of Device

  ON (B)(6) 2021, BELMONT MEDICAL TECHNOLOGIES (B)(4) REPORTED THE FOLLOWING: "SYSTEM ERROR 101. THE CASE WAS A PELVIC EXENTERATION WHICH IS A SPECIALIST OPERATION WHICH IS ONLY CARRIED OUT IN 2 HOSPITALS IN THE (B)(6), DURING THE OPERATION VARIOUS PRODUCTS WERE INFUSED, IN THE MAIN BLOOD, FFP AND A COUPLE OF UNITS OF HARTMANS SOLUTION. THE PROCEDURE STARTED AROUND 9AM AND EVERYTHING WAS GREAT THROUGHOUT THE DAY, INFUSION RATES WERE VERY GOOD AND REACHING THE LEVELS REQUIRED. INFUSION RATES WENT FROM VERY LOW TO VERY HIGH AS AND WHEN NEEDED AND IT WAS NOTED THAT STAFF HAD TO KEEP PRESSING SET RATE TO MATCH ACTUAL RATE SEVERAL TIMES AS THE MACHINE STRUGGLED TO DELIVER WHAT WAS BEING ASKED OF IT. AROUND 11PM DURING A MASSIVE BLEED THE MACHINES SCREEN PIXILATED AND THEN CAME UP WITH THE 101 ERROR MESSAGE, AS PER INSTRUCTIONS ON SCREEN THE CIRCUIT WAS REMOVED AND BLOOD WASTED, THE TEAM HAD TO MANUALLY SQUEEZE BLOOD PRODUCTS IN BY HAND WHILE SWAPPING TO THE LEVEL 1 INFUSER." ON (B)(6) 2021, BELMONT MEDICAL TECHNOLOGIES SUBSEQUENTLY RECEIVED THE FOLLOWING (B)(6) REPORT: "DETAILS OF INCIDENT / NATURE OF DEVICE DEFECT TEST: AFTER PROLONGED USE (AROUND 1020H - 2300H), THE BELMONT RAPID INFUSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763824 ↗
• MalfunctionAug 12, 2021Electrical /Electronic Property Problem; Electrical Overstress; Electrical /Electronic Property Problem; Electrical Overstress

  BELMONT MEDICAL TECHNOLOGIES RECEIVED A REPORT THAT A PATIENT UNDERGOING A VASCULAR TREATMENT AT (B)(6) HOSPITAL IN (B)(6) WAS INVOLVED IN AN EQUIPMENT ISSUE ON (B)(6) 2021. THE REPORT STATED THE FOLLOWING: "BELMONT RAPID INFUSER BEING USED TO DELIVER FLUID DURING URGENT SURGERY FOR RUPTURED AORTIC ANEURYSM. POWER CUT OFF TO ENTIRE THEATRE AND TRACED TO THE FLUID WARMER. UNABLE TO DISCONTINUE FLUID DELIVERY DUE TO DETERIORATING PATIENT AND ESTATES DEPARTMENT INITIALLY CALLED TO HOLD CIRCUIT BREAKER ON, HOWEVER PATIENT DIED ON TABLE."

  Patient problems: Ruptured Aneurysm

  MAUDE report 12317014 ↗
• MalfunctionJun 11, 2021No Visual Prompts/Feedback; No Tactile Prompts/Feedback; No Visual Prompts/Feedback; No Tactile Prompts/Feedback

  BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING REPORT (REPORT NUMBER: (B)(4)) FROM THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY ((B)(6)) IN THE UK: "TOUCH SCREEN BECAME UNRESPONSIVE DURING AN OPERATION, THE RAPID INFUSER WAS DELIVERING FLUID TO THE PATIENT, HOWEVER WHEN THE CLINICAL TEAM TRIED TO INCREASE THE FLOW RATE THERE WAS NO RESPONSE TO THE KEY PRESSES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988140 ↗
• MalfunctionDec 18, 2020Electrical /Electronic Property Problem; Electrical Overstress; Electrical /Electronic Property Problem; Electrical Overstress

  BELMONT MEDICAL TECHNOLOGIES RECEIVED A REPORT FROM THE USER FACILITY THAT THE POWER WENT OFF IN THE OR WHILE THE BELMONT RAPID INFUSER, RI-2 WAS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11041383 ↗
• MalfunctionNov 27, 2020Overheating of Device; Overheating of Device

  BELMONT MEDICAL TECHNOLOGIES' DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND REPORTED THE FOLLOWING, "BELMONT RI-2, WAS PREPPED FOR USE BY PERFUSION TEAM. ALARM WAS RAISED WHEN SMOKE CAME FROM DEVICE. DISPOSABLE SET MELTED IN UNIT. VERBAL CONFIRMATION WAS PROVIDED BY THE REPORTING CUSTOMER THAT HARTMANN'S SOLUTION WAS BEING USED IN THE DEVICE AT THE TIME OF THE INCIDENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10915164 ↗
• MalfunctionNov 21, 2018Circuit Failure; Circuit Failure

  THE USER FACILITY REPORTED THAT THE RAPID INFUSER WAS USED TO INFUSE 12 UNITS OF BLOOD, AND THEN RAN ON BATTERY MODE WHILE THE PATIENT WAS MOVED TO CT. WHEN IT WAS LATER PLUGGED BACK INTO THE SAME SOCKET, THE UNIT TRIPPED THE CIRCUIT BREAKER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8097844 ↗