English, Rapid Infuser RI-2, 230V, 750 ml/min 903-00039ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10896128002777), received between Jun 19, 2019 and Mar 21, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Pressure Problem; Excessive Heating; Pressure Problem; Excessive Heating

  THE USER FACILITY REPORTED OVER TEMPERATURE AND POSSIBLE PRESSURE ERRORS DURING USE OF SURGERY CASE. THE PATIENT INVOLVED IN THE INCIDENT PASSED DUE TO CARDIAC ARREST BUT BELMONT IS NOT BEING NOTED AS CONTRIBUTING TO THE PATIENT DEATH.

  Patient problems: Insufficient Information

  MAUDE report 18956710 ↗
• MalfunctionJul 22, 2020Device Sensing Problem; Device Sensing Problem

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "DURING A MAJOR RESUSCITATION THIS MORNING, THE DEVICE FAILED ON STARTUP. IT WENT STRAIGHT TO THE CALIBRATION/SET-UP SCREEN AND THE EXIT SERVICE BUTTON DID NOT RESPOND. THEY REBOOTED THE RI-2 COMPUTER AND CHANGED THE AC POWER SOURCE REPEATEDLY HOWEVER IT DID NOT RESOLVE THE ERROR."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311705 ↗
• MalfunctionJul 22, 2020Increase in Pressure; Temperature Problem; Increase in Pressure; Temperature Problem

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "REPEATED INSTANCES OF 'HIGH PRESSURE DETECTED' AND 'TEMPERATURE ALARM' EVEN WHEN NOT BEING USED. OUR ENGINEER HAS ASSESSED IT AND FOUND THE FOLLOWING: CUSTOMER HAS HAD REPEATED TEMPERATURE AND PRESSURE SENSORS, EVEN WHEN THE UNIT HAS NOT BEEN IN USE (SET INSERTED, BUT NOT RUNNING). UNREPORTED UNTIL NOW. UNIT RECENTLY SENT TO GETZ ((B)(6) 2020) FOR ERROR 101 AND PASSED WARRANTY PM WITH NO ISSUES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311394 ↗
• MalfunctionJun 18, 2020Complete Loss of Power; Complete Loss of Power

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "THE LIVER TRANSPLANT SURGERY WAS SCHEDULED ON SATURDAY, MAY 16TH. THE UNIT WAS PREPARED AND THE DISPOSABLES (903-00004, 903-00006, AND 903-00018) WAS ATTACHED AND PRIMED AS USUAL. THE UNIT WAS IN OPERATION AND THE SURGERY WAS GOING WELL UNTIL THIS PROBLEM CAME UP. THE UNIT HAD POWER FAILURE AND IMMEDIATELY SHUT DOWN THE SYSTEM. THE STAFFS TRIED TO RESTART THE SYSTEM, BUT THE POWER WAS COMPLETELY GONE. THE STAFF CONTACTED US THE EMERGENCY ASSISTANCE AND WE INSTALLED THE REPLACEMENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10171887 ↗
• MalfunctionFeb 12, 2020Output Problem; No Tactile Prompts/Feedback; Output Problem; No Tactile Prompts/Feedback

  BELMONT'S DISTRIBUTER RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT. "THE TOUCH SCREEN INTERMITTENTLY STOP FUNCTION. A PATIENT GOT TRANSFUSED IN VARIOUS SPEED IN A PERIOD OF 90 MINUTES BECAUSE OF A BLEEDING AORTA. BUT ON THE LAST PHASE OF THESE 90 MINUTES THEY SCALED IT DOWN TO 50 ML/MIN, AFTER THIS IT CAME AN ERROR (101) THAT WAS POSSIBLE TO OVERRIDE, WHICH THEY DID AND THEN IT WENT UP TO 750 ML/MIN AUTOMATICALLY AND IT WASN'T POSSIBLE TO TURN THE SPEED DOWN. IT WAS CONSTANTLY ON 750 ML/MIN. WHEN THEY TRIED TO PRESS "STOP", THE MACHINE THE STOPPED AS LONG AS THEY HOLD THE BUTTON IN, BUT IT CONTINUED AT 750 ML/MIN WHEN THEY RELEASED THE BUTTON. FROM THERE THEY DIDN'T WASNT TO RISK THE PATIENT LIFE AND THEY HAD TO GET THE OTHER BELMONT THEY HAVE AT THEIR HOSPITAL."

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

  MAUDE report 9703206 ↗
• MalfunctionJun 19, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE USER FACILITY REPORTED TO OUR DISTRIBUTOR THAT, DURING A PROCEDURE, THERE WAS A SPARK AND THE UNIT STOPPED WORKING. THE DOCTOR HAD THE STAFF SWITCH TO AN FMS 2000 AND THE OPERATION WAS COMPLETED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8713824 ↗