English, Rapid Infuser RI-2, 230V, 1000 ml/min 903-00037ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10896128002753), received between Nov 22, 2019 and Sep 18, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Pressure Problem

  During the procedure, the RI-2 was used to administer blood products and fluids for volume resuscitation. Repeated high-pressure alarms occurred, resulting in difficulty delivering the required fluid. Inspection identified a kink in one foot cannula and reisstance in a second cannula, which required manual flushing to establish patency. Although both cannulas were subsequently able to be flushed manually, repeated high-pressure alarms continued on the RI-2.

  Patient problems: Insufficient Information

  MAUDE report 50820547 ↗
• MalfunctionFeb 17, 2026No Display/Image

  IT WAS REPORTED THAT AN RI-2 UNIT POWERED ON AND THE LED INDICATOR FLASHED; HOWEVER, THE DISPLAY REMAINED BLANK. THE DEVICE HAD BEEN IN USE FOR AN EXTENDED PERIOD DURING A MASSIVE TRANSFUSION, DURING WHICH APPROXIMATELY FIVE MASSIVE TRANSFUSION PACKS WERE ADMINISTERED USING BLOOD PRODUCTS COMPATIBLE WITH THE RI-2. AFTER THE ISSUE OCCURRED, A REPLACEMENT BELMONT UNIT FROM THEATRE WAS TEMPORARILY USED. THE PATIENT LATER DIED DUE TO SIGNIFICANT INJURIES; THE USER FACILITY CONFIRMED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE RI-2 DEVICE OR ITS TEMPORARY UNAVAILABILITY.

  Patient problems: Insufficient Information

  MAUDE report 24369312 ↗
• MalfunctionNov 21, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN EC ADMINISTRATION, THE RAPID INFUSER AUTOMATICALLY INCREASED THE FLOW RATE TO 500 ML/MIN ON FIVE SEPARATE OCCASIONS, DESPITE THE SET FLOW RATE BEING 50 ML/MIN. DURING EACH OCCURRENCE, THE CHANGE IN FLOW WAS DETECTED BY THE USER BASED ON THE NOISE GENERATED BY THE DEVICE WHEN THEY HAD STEPPED AWAY. THERE WAS NO PATIENT INJURY. THE DEVICE WAS TAKEN OUT OF SERVICE FOLLOWING THE EVENT AND REPLACED WITH ANOTHER UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621597 ↗
• MalfunctionAug 13, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THE DEVICE HAS A FUNCTIONAL ERROR, IT SWITCHES OFF AND DISPLAYS: 'TEMPERATURE ERROR' AND THE TEAM HAD TO RESTART TO CONTINUE THE TRANSFUSION. LOT # 20231212. DEVICE USED FOR ABOUT 1 HOUR. FLOW RATE 200 ML/MIN. 3L RESERVOIR WAS USED. RUNNING ON AC POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800376 ↗
• MalfunctionMay 8, 2025Failure to Calibrate; Failure to Calibrate

  THE USER FACILITY REPORTED THAT, "THE DEVICE HAS REPORTEDLY LOST ITS CALIBRATION. THIS CAUSED A DELAY FOR USERS STARTING AN INFUSION ON A PATIENT. AS A RESULT OF THIS FAILURE, DURING A CASE IT DELAYED USERS FROM STARTING AN INFUSION/TRANSFUSION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986440 ↗
• MalfunctionJan 9, 2025Display Difficult to Read; Display Difficult to Read

  ON OCTOBER 16, 2024 DISTRIBUTOR REPORTED THAT FLUID INGRESS HAS CAUSED THE DISPLAY TO FAIL. NO PATIENT IMPACT WAS REPORTED. DISTRIBUTOR NOTES GAPS IN THE RTV THAT MAY HAVE RESULTED IN THIS. THE DISTRIBUTOR WILL REPLACE THE PART AND ADDRESS THE RTV. THE INCIDENT DID NOT MEET THE CRITERIA TO BE REPORTED. SUBSEQUENTLY ON DECEMBER 11TH, 2024 BELMONT RECEIVED USER FACILITY REPORT REFERENCE (B)(4) . FROM SWISSMEDIC WHICH CONTAINED ADDITIONAL INFORMATION AND THE DECISION TO REPORT / RESPOND WAS MADE. THE ADDITIONAL INFORMATION STATES "SCREEN DEFECT. THE DEVICE COULD BE SWITCHED ON, BUT THE DISPLAY WAS BLACK. AFTER CONSULTING WITH THE MANUFACTURERS REPRESENTATIVE, A "WEAK POINT" WAS POINTED OUT. THIS IS, ON THE ONE HAND, THE RUBBER SEAL AROUND THE SCREEN AND, ON THE OTHER HAND, THE DISPLAY ITSELF, WHICH COULD BE DAMAGED BY LIQUID AND FALLING PARTS. WHEN ASKED WHAT SOLUTION WOULD BE POSSIBLE FROM THE MANUFACTURER, THEY SIMPLY SAID THEY WERE TRYING TO FIND A SOLUTION. A "SELF-MADE PLEXIGLAS DEVICE" FROM THE MEDICAL TECHNOLOGY DEPARTMENT AT THE UNIVERSITY HOSPITAL OF BASEL HAS BEEN MENTIONED. THEY ARE SATISFIED WITH THE PRODUCT. A CORRESPONDING REQUEST WAS MADE TO THE IN-HOUSE MEDICAL TECHNOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118886 ↗
• MalfunctionOct 30, 2024Defective Device; Defective Device

  THE MIR DETAILED THE FOLLOWING INCIDENT. CLINICAL STAFF TRIED TO USE RAPID INFUSER BUT THE DEVICE WAS NOT WORKING AND NO REPLACEMENT WAS AVAILABLE. PATIENT WAS TRANSFERRED TO THEATRE AND BLOOD HAD TO BE PUSHED THROUGH MANUALLY BY ANESTHETIST IN THE LIFT. WHILE PATIENT WAS BEING TRANSFERRED ANOTHER MEMBER OF STAFF TRIED TO SET UP THE SPARE RAPID INFUSER, A RANGER 3M, BUT THE CARTRIDGE TO INSERT THE GIVING SET INTO WAS MISSING FROM THE DEVICE. USED PRESSURE BAGS AND FLUID WARMER TO INFUSE BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570581 ↗
• MalfunctionJan 13, 2021Electrical Overstress; Electrical Overstress

  BELMONT'S DISTRIBUTOR RECEIVED A REPORT INVOLVING A BELMONT RAPID INFUSER, RI-2 FROM THE CLINICAL ENGINEER AT THE HOSPITAL AND RELAYED THE FOLLOWING REPORT: "CAREGIVER WERE SETTING UP OR FOR AN EMERGENCY CASE AND THEY NOTICED THAT POWER LINE IN WHICH DEVICE WAS CONNECTED WAS TRIPPED. THERE WERE OTHER DEVICES IN SAME LINE AND COMPLETE LINE WAS TRIPPED. THIS DEVICE WAS ISOLATED AND FOUND TO BE CAUSE FOR TRIPPING IN MCB AND ONE OF THE CAREGIVER MENTIONED TO HEAR A NOISE FROM THE DEVICE BEFORE TRIPPING. NO PATIENT WAS AFFECTED BUT CAUSED DELAY IN THE PROCEDURE DURING PREPARATION. INSPECTED OTHER DEVICES IN SAME LINE AND THEY FOUND TO BE WORKING GOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11158770 ↗
• MalfunctionDec 24, 2020Insufficient Heating; Insufficient Heating

  BELMONT'S DISTRIBUTOR RECEIVED A REPORT FROM THE USER FACILITY THAT THE BELMONT RAPID INFUSER, RI-2 EXHIBITED A "HEATING FAULT" ALARM AT A FLOW RATE OF 10ML/MIN WITH AN OUTPUT TEMPERATURE OF 36.5 TO 37.0 DEGREES C.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072179 ↗
• MalfunctionJan 17, 2020Electrical /Electronic Property Problem; Complete Loss of Power; Electrical /Electronic Property Problem; Complete Loss of Power

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "THE UNIT IMMEDIATELY TURNED OFF RIGHT AFTER TURNED ON THE SWITCH ON THE BACK OF THE UNIT. THEN ALL OF ELECTRICITY IN THE OR SHUT DOWN AND THE UPS WAS ACTIVATED. THE HOSPITAL'S ENGINEERING DEPARTMENT SUSPECTED THE RI-2 WAS THE CAUSE OF THE PROBLEM IN THE OR. THE ENGINEER AT THE HOSPITAL CALLED ACME REGARDING THE COMPLAINTS AND ACME RESPONDED IMMEDIATELY AND INSTALLED THE REPLACEMENTS. AFTER RETRIEVING THE UNIT, ACME CHECKED THE UNIT IN THEIR LAB AND THE UNIT TURNED OFF IMMEDIATELY WHEN THEY PLUGGED ON AND POWERED UP. NOW, THE UNIT IS UNABLE TO TURN ON."

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

  MAUDE report 9603849 ↗
• MalfunctionNov 22, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  OUR DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "DURING A CASE, THE RI-2 SUDDENLY STOPPED RUNNING ON AC AND WAS IN BATTERY OPERATION. WE CHECKED AND FOUND OUT THE POWER OUTLET WAS TRIPPED, THIS HAPPENED ONLY AFTER 4 HOURS THROUGH THE CASE. IMMEDIATELY WE SWAPPED TO ANOTHER FMS FOR BACKUP."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365870 ↗