3.0 Liter Reservoir (1 Piece) 903-00018PRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00896128002008), received between Sep 23, 2015 and Nov 22, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation

  DURING A PROCEDURE WITH AN ACUTELY BLEEDING TRAUMA PATIENT, AN ACCIDENTAL INCIDENT OCCURRED WITH A 3L RESERVOIR. WHERE THE RETURN HOSE IS CONNECTED TO THE RESERVOIR, THE WELD BROKE IN THE MIDDLE OF THE TRANSFUSION, AND THE BLOOD STARTED GUSHING OUT OVER THE RAPID INFUSER. THIS HAPPENED AFTER THE TRAUMA STAFF HAD BEEN WORKING FOR ABOUT 45 MINUTES WITH THE RAPID INFUSER. THE BELMONT'S DISTRIBUTOR CONFIRMED ON (B)(6) 2022, THAT THERE WAS NO PATIENT INJURY AS A RESULT OF THE REPORTED INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849476 ↗
• MalfunctionMay 15, 2021Obstruction of Flow; Obstruction of Flow

  THE USER FACILITY REPORTED THE FOLLOWING: "THEY WERE RUNNING THE BELMONT WITH THEIR STANDARD SETUP (3.0 L RESERVOIR) DURING A TRAUMA CASE. THE PATIENT ARRESTED AND THEY NEEDED TO DO CPR. DURING CPR IT WAS RECOGNIZED THAT THE BLOOD IN THE RESERVOIR HAD PARTIALLY BEEN CLOTTED."

  Patient problems: Insufficient Information

  MAUDE report 11830099 ↗
• MalfunctionJan 15, 2021Fluid/Blood Leak

  BELMONT'S DISTRIBUTOR RECEIVED A REPORT FROM THE USER FACILITY ABOUT A 3.0 LITER RESERVOIR AND REPORTED THE FOLLOWING: "BLOOD LEAKED FROM THE BOTTOM PORT OF THE RESERVOIR WHILE USING THE LARGE SET. THE EXACT PART COULD NOT BE CONFIRMED. THE KIT WAS DISCARDED ON SITE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11181547 ↗
• MalfunctionJan 15, 2021Fluid/Blood Leak; Material Separation

  BELMONT'S SALES REPRESENTATIVE RECEIVED A REPORT FROM THE USER FACILITY THAT A 3.0 LITER RESERVOIR WAS LEAKING DURING A CASE. THE USER REPORTED THAT TWO OF THE FIVE SPIKES WERE LOOSE; THE BLOOD PRODUCT WAS SWITCHED TO THE SPIKES THAT WERE NOT LOOSE. THE USER ALSO REPORTED THAT A SIMILAR INCIDENT RECENTLY OCCURRED DURING A TRAUMA CASE, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11179921 ↗
• MalfunctionDec 12, 2020Increase in Pressure; Failure to Prime; Increase in Pressure; Failure to Prime

  BELMONT RECEIVED A REPORT FROM THE PHYSICIAN AT THE HOSPITAL ABOUT AN INCIDENT THAT OCCURRED ON (B)(6) 2020, INVOLVING A 3.0 LITER RESERVOIR: "THIS PARTICULAR DISPOSABLE DEVICE FAILED THIS MORNING. IT WAS FOR AN EMERGENCY CASE, PT WITH MULTIPLE GUNSHOT WOUNDS, BLEEDING SEVERELY, WITH UNSTABLE VITAL SIGNS, MASSIVE TRANSFUSION PROTOCOL IN PROGRESS. UPON TRYING TO PRIME THE BELMONT FMS 2000 WITH NORMOSOL, A HIGH PRESSURE ALARM KEPT GOING OFF INDICATING HIGH PRESSURE IN THE RETURN LINE TO THE 3 LITER RESERVOIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995849 ↗
• MalfunctionNov 11, 2020Material Separation; Material Separation

  BELMONT'S DISTRIBUTOR RECEIVED A REPORT FROM THE USER FACILITY THAT THE SPIKES OF A 3.0 LITER RESERVOIR CAME LOOSE DURING A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10826646 ↗
• MalfunctionOct 14, 2020Overheating of Device; Overheating of Device

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY INVOLVING THREE DISPOSABLE PRODUCTS (3-SPIKE DISPOSABLE SET, 3.0 LITER RESERVOIR, AND DUAL PATIENT LINE) AND REPORTED THE FOLLOWING: "DURING 'TOTAL ABDOMINAL HYSTERECTOMY', #102 OVER TEMPERATURE ERROR OCCURRED USING RI-2. THE USER HAS REPLACED THE NEW DISPOSABLE KIT." THIS REPORT IS FOR THE 3.0 LITER RESERVOIR. SEPARATE REPORTS WILL BE ENTERED FOR THE 3-SPIKE DISPOSABLE SET AND DUAL PATIENT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10681429 ↗
• MalfunctionSep 24, 2020Overheating of Device; Overheating of Device

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY INVOLVING THREE DISPOSABLE PRODUCTS (3-SPIKE DISPOSABLE SET, 3.0 LITER RESERVOIR, AND DUAL PATIENT LINE) AND RELAYED THE FOLLOWING REPORT: "DURING OPEN HEART SURGERY, #102 OVER TEMPERATURE ERROR OCCURRED AFTER ABOUT 5 HOURS OF USING RI-2. THE USER HAS REPLACED THE NEW DISPOSABLE KIT." THIS REPORT IS FOR THE 3.0 LITER RESERVOIR; SEPARATE REPORTS WILL BE ENTERED FOR THE 3-SPIKE DISPOSABLE SET AND DUAL PATIENT LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10584575 ↗
• MalfunctionAug 20, 2020Material Separation; Material Separation

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY THAT THE SPIKES ON P/N 903-00018P CAME LOOSE FROM THE TUBING ON THREE OCCASIONS ((B)(6) 2020, (B)(6) 2020, AND (B)(6) 2020), WHICH MADE IT "VERY TROUBLESOME TO CHANGE FLUID/BLOOD BAGS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10429340 ↗
• MalfunctionAug 20, 2020Material Separation; Material Separation

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY THAT THE SPIKES ON P/N 903-00018P CAME LOOSE FROM THE TUBING ON THREE OCCASIONS ((B)(6) 2020, (B)(6) 2020, AND (B)(6) 2020), WHICH MADE IT "VERY TROUBLESOME TO CHANGE FLUID/BLOOD BAGS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10429329 ↗
• MalfunctionAug 19, 2020Material Separation; Material Separation

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY THAT THE SPIKES ON P/N 903-00018P CAME LOOSE FROM THE TUBING ON THREE OCCASIONS (B)(6) 2020, WHICH MADE IT "VERY TROUBLESOME TO CHANGE FLUID/BLOOD BAGS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10429290 ↗
• MalfunctionAug 12, 2020Material Separation; Material Separation

  BELMONT'S SALES REPRESENTATIVE RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "DURING LIVER TRANSPLANT CASE THE PROVIDERS WERE INFUSING BLOOD PRODUCTS AND NOTICED LEAKING. THE ANESTH TECH NOTICED THAT THE PRIMING TUBING WAS MISSING SPIKES AND THE BAGS WERE BEING INSERTED DIRECTLY INTO THE TUBING, WHICH CAUSED THE LEAKAGE. NEW LVR WAS CONNECTED AND CASE CONTINUED WITH NO FURTHER PROBLEMS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10399505 ↗
• MalfunctionDec 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "LEAKAGE, LOWER PART OF THE RESERVOIR."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9433481 ↗
• MalfunctionSep 23, 2015Adverse Event Without Identified Device or Use Problem

  THE REPORT FROM THE USER FACILITY DESCRIBES AN EVENT IN WHICH SALINE AND A NUMBER OF BLOOD PRODUCTS WERE BEING INTRODUCED INTO A PATIENT IN RESPONSE TO SURGERY-INDUCED HYPOVOLEMIA AT A RATE OF 500 ML/MIN. AFTER 500 TO 1000 ML OF PRODUCTS WERE INFUSED, THE PATIENT BEGAN TO EXPERIENCE TACHYCARDIA AND A DROP IN BLOOD PRESSURE, WHICH WERE MANAGED WITH PRESSORS. THE SYSTEM WAS PROPHYLACTICALLY REPLACED AND A SIMILAR EVENT OCCURRED SUBSEQUENTLY 4 HOURS LATER DURING A BOLUS OPERATION OF THE REPLACEMENT SYSTEM. THIS WAS THE FIRST INCIDENT WHERE A BOLUSING OF BLOOD PRODUCTS WAS NOTICED TO CAUSE A HYPOTENSIVE EVENT. FOLLOWING THIS EVENT, THERE WERE 4 SIMILAR CASES. IT WAS NOTED THAT OF THE 5 CASES, A TOTAL OF 4 PATIENTS WERE RECEIVING ACE INHIBITORS. IT WAS ALSO NOTED THAT THE RESERVOIR FILTER ASSEMBLY HAD BEEN REDESIGNED THE PREVIOUS YEAR. BELMONT ENGINEERING RESPONDED TO THE INITIAL INQUIRY BY MEETING WITH THE HOSPITAL PERSONNEL IN ORDER TO UNDERSTAND THE SITUATION. THE HOSPITAL PERSONNEL SPECULATED THAT THE CHANGE IN THE FILTER MIGHT BE CAUSING THE GENERATION OF BRADYKININS IN THE BLOOD.

  Patient problems: Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 5098666 ↗

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