Dual Patient Line (1 Piece) 903-00004PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00896128002053), received between Dec 6, 2019 and Dec 21, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2022Leak/Splash; Leak/Splash

  IN A PATIENT UNDERGOING MAJOR SURGERY, THE "RAPID INFUSOR 2" WAS CONNECTED TO BOTH LEGS OF A SHALDON CATHETER USING A "DUAL PATIENT LINE" Y-LINE SET AND WAS NOT USED FOR A FEW HOURS. WHEN THE SYSTEM WAS CHECKED VISUALLY BEFORE THE START OF THE TRANSFUSION, A LARGE AMOUNT OF AIR WAS NOTICED IN THE SYSTEM. SINCE AT THAT TIME IT COULD NOT BE RULED OUT WITH CERTAINTY THAT AIR HAD REMAINED IN THE SYSTEM DUE TO AN ERROR IN THE PREPARATION (UNLIKELY, BUT THERE WAS A TEAM CHANGE IN THE MEANTIME), THE AIR WAS DRAWN OFF VIA THE INJECTION CONNECTORS. IT WAS NOTICED THAT THERE WAS LIQUID ON THE FLOOR BELOW THE Y-PIECE. A PRESSURE TEST SHOWED A CLEAR LEAK. IT CAN BE ASSUMED THAT THE AIR ALSO GOT INTO THE SYSTEM VIA THIS LEAK, BECAUSE THE INFUSION SOLUTION HAD ESCAPED DUE TO GRAVITY WHILE THE VEHICLE WAS STANDING STILL. THE PATIENT WAS NOT HARMED BECAUSE AIR AND LEAKS WERE NOTICED IN GOOD TIME AND THE Y-SYSTEM WAS REMOVED. WE SECURED THE SYSTEM AND SHUT DOWN ALL OTHER SYSTEMS.

  Patient problems: Insufficient Information

  MAUDE report 16022859 ↗
• 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 DUAL PATIENT LINE; SEPARATE REPORTS WILL BE ENTERED FOR THE 3-SPIKE DISPOSABLE SET AND 3.0 LITER RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10681430 ↗
• 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 DUAL PATIENT LINE; SEPARATE REPORTS WILL BE ENTERED FOR THE 3-SPIKE DISPOSABLE SET AND 3.0 LITER RESERVOIR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10584597 ↗
• MalfunctionJul 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY STATING THAT THERE WAS A LEAK AT THE Y-CONNECTOR OF THE DUAL PATIENT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10220776 ↗
• MalfunctionDec 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "CLAMPS BROKEN, BLOOD INFLOW."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9433604 ↗

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