3-Spike Disposable Set (1 Piece) 903-00006PRecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00896128002022), received between Sep 26, 2018 and Feb 20, 2026 — classified as 1 death, 1 injury, 95 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (46 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Jan 2, 2025Class IIOpen, Classified

   Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set

   Z-1099-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Material Separation

  IT WAS REPORTED THAT DURING USE, THE 3-SPIKE DISPOSABLE SET SEPARATED IN BETWEEN THE FLUID OUTLET PLASTIC BLOCK AND THE SMALL RESERVOIR. AS A RESULT, ALL SPIKED FLUID PRODUCTS LEAKED OVER THE RI-2 UNIT. THE PATIENT LATER DIED; HOWEVER, IT WAS CONFIRMED THAT THE PATIENT DEATH WAS NOT RELATED TO THE RI-2 OR THE DISPOSABLE SET.

  Patient problems: Insufficient Information

  MAUDE report 24405881 ↗
• MalfunctionDec 22, 2025Overheating of Device; Overheating of Device

  THERE WERE MULTIPLE DISPOSABLE SETS INVOLVED IN AN OVERHEAT INCIDENT DURING A CASE. NO DETAILS EXCEPT FOR THE LOT # 20250707. DURING USE BOTH OF OUR BELMONT DEVICES DISPLAYED TEMPERATURE ERROR MESSAGES AND COMPLETELY FAILED TO INFUSE WHEN USED WITH TUBING FROM LOT # 20250707. NO ISSUES OCCURRED WHEN SWITCHING TO TUBING FROM ANOTHER LOT. THE TUBING WAS ATTEMPTED ON TWO SEPARATE MACHINES. BOTH UNIT'S DISPLAYED A SYSTEM ERROR 102. ONE MACHINE IS OFF THE UNIT CURRENTLY BUT THE S/N FOR THE OTHER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871421 ↗
• MalfunctionJun 18, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT 2 DISPOSABLE SETS FROM LOT#20240506 HAD AN ISSUE OF FLUID LEAKING THROUGH THE VENT CAP. ONE DURING TRAINING AND ONE DURING MTP ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287015 ↗
• MalfunctionApr 24, 2025Leak/Splash; Leak/Splash

  THE MEDSUN REPORT #(B)(4) STATED THAT, "DUE TO ACTIVE BLEEDING, A PATIENT WAS REQUIRING THE MASSIVE TRANSFUSION PROTOCOL. THE PATIENT WAS CRITICALLY ILL. THE STAFF SET-UP THE BELMONT RAPID INFUSER TO INFUSE THE BLOOD. AS THE BLOOD WAS INFUSING, THE STAFF NOTICED THE TUBING WAS LEAKING AND CAUSING THE BLOOD LEAK OUT. UPON EXAMINATION OF THE TUBING, THE STAFF NOTICED THE TUBING WAS CRACKED ABOVE THE BLUE ARROW. THE TUBING WAS REMOVED AND A 2ND SET OF TUBING WITH A DIFFERENT LOT NUMBER WAS UTILIZED. THE PATIENT DID NOT RECEIVE ALL THE BLOOD FROM THE UNIT TRANSFUSING. THE PATIENT DID HAVE A CARDIAC ARREST AND DID NOT SURVIVE".

  Patient problems: Insufficient Information

  MAUDE report 21904155 ↗
• MalfunctionMar 27, 2025Material Separation; Connection Problem; Material Separation; Connection Problem

  THE USER FACILITY USER REPORTED THAT 2 OF THE THREE SPIKES FROM THE SET SPONTANEOUSLY DISCONNECT MID CASE. UNFORTUNATELY, THE PACKAGING WAS NOT KEPT - BUT THE LOT# IS OF THE NEXT SET IN THE CUPBOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21715804 ↗
• MalfunctionMar 14, 2025

  BELMONT TUBING LEAKED FROM A SPECIFIC PART OF THE TUBING, MAKING IT NONFUCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605244 ↗
• MalfunctionMar 6, 2025Material Separation; Connection Problem; Material Separation; Connection Problem

  DURING MASSIVE TRANSFUSION AND SURGERY DUE TO HEART STABBING THE RI-2 WAS SET UP IN ED THEN TRANSFERRED WITH THE PATIENT TO THEATRE FOR SURGERY. >50L OF BLOOD AND IV FLUIDS WERE GIVEN RAPIDLY VIA A RIC IN THE FEMORAL VEIN AT 750 ML/MIN, THEN A CENTRAL CATHETER IN THE SVC (400-500 MLS/MIN) WHEN THE RIC FAILED. DURING THE PROCEDURE A SPIKE DISCONNECTED FROM THE INITIAL 903-00006 KIT FROM ED, WITH RESULTING BLOOD SLASH TO STAFF. INFUSION CONTINUED VIA REMAINING 2 SPIKES WHILE ANOTHER RI-2 WAS PRIMED WITH A NEW KIT. FOLLOWING FURTHER MASSIVE TRANSFUSION, ANOTHER SPIKE DISCONNECTED, FROM THE 2ND KIT, WITH BLOOD SPLASH TO STAFF AND INTERRUPTION OF INFUSION TO PATIENT. BOTH FAILED KITS WERE REPLACED AND INFUSION CONTINUED WITH A 3RD KIT. DESPITE EFFECTIVE TRANSFUSION OVER HOURS, ON THE RI- 2, THE PATIENT DIED FROM THEIR INJURIES. THIS WAS NOT CONSIDERED TO BE DUE TO THE SPIKE DISCONNECTIONS. THE STAFF ARE CONCERNED ABOUT THE 2 SPIKE DISCONNECTIONS AND BLOOD SPLASH RISK TO STAFF PLUS THE ADDITIONAL DEGREE OF DIFFICULTY/STRESS/INCONVENIENCE DURING A COMPLEX MTP RESUSCITATION. KITS: NO KITS WERE RETAINED DUE TO EXTENSIVE BLOOD CONTAMINATION AND NO PHOTOS WERE TAKEN DUE TO LACK OF TIME IN AN

  Patient problems: Insufficient Information

  MAUDE report 21538235 ↗
• MalfunctionMar 6, 2025Break; Break

  THE ED STAFF REPORTED A TUBING HAD TORN AND BLOOD RAN ALL OVER THE UNIT. THEY WERE ABLE TO WIPE IT ALL DOWN AND IT IS ALSO DUE FOR A (B)(6) 2025 PM.

  Patient problems: Insufficient Information

  MAUDE report 21537284 ↗
• MalfunctionFeb 12, 2025Obstruction of Flow; Obstruction of Flow

  THE MEDWATCH #MW5163140 STATED THE FOLLOWING: BELMONT RAPID INFUSER HAD BLOOD CLOTS IN AND AROUND THE FILTER AND THROUGH THE ENTIRE LINE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21370763 ↗
• MalfunctionFeb 12, 2025Obstruction of Flow; Obstruction of Flow

  THE MEDWATCH # MW5163189 STATED THE FOLLOWING: BELMONT RAPID INFUSER INFUSION SETS HAD FAILED FILTERS. BLOOD WAS CLOTTING IN AND AROUND THE FILTERS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21370458 ↗
• MalfunctionOct 18, 2024Melted; Device Emits Odor; Smoking; Melted; Device Emits Odor; Smoking

  THE USER FACILITY REPORTED THAT THERE WAS AN OVERHEAT ERROR DURING A CASE BY USING WHOLE BLOOD. THE DISPOSABLE SET WAS REMOVED AND INSTALLED ON ANOTHER RI-2. THE STAFFS WERE ABLE TO INFUSE AT 500 ML/MIN FOR 30 MINUTES NONSTOP AND THAT WAS WHEN THE TEAM NOTICED A SMELL AND SAW SMOKE. THE DISPOSABLE SET WAS DISCARDED. THERE WERE 2 UNITS USED, ONE FROM ER WHICH I DO NOT KNOW THE SERIAL NUMBER, THE OTHER WAS ONE OF OURS BUT I DO NOT RECALL WHICH OF THE 2 UNITS WE HAVE, ONE SERIAL NUMBER IS (B)(6), THE OTHER IS (B)(6), THE TUBING LOT NUMBER IS 20240415.

  Patient problems: Insufficient Information

  MAUDE report 20487103 ↗
• MalfunctionOct 17, 2024Material Separation; Connection Problem; Material Separation; Connection Problem

  IT WAS REPORTED THAT PATIENT HAD BLOOD TRANSFUSION PROTOCOL. THE BELMONT#5 WAS USED. DURING USE, THE WHITE SPIKE (THAT INSERTS INTO THE BAGS) AND IS CONNECTED TO PLASTIC TUBING BECAME DISCONNECTED. THIS HAPPENED ON 2 OF THE 3 WHITE SPIKE CONNECTORS ON THE CIRCUIT. BUT THIS WAS CAUGHT IN TIME FOR NO HARM TO OCCUR. NO PATIENT HARM HAS BEEN REPORTED TO BELMONT AS A RESULT OF THE ALLEGED INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478144 ↗
• MalfunctionOct 10, 2024Leak/Splash; Infusion or Flow Problem; Leak/Splash; Infusion or Flow Problem

  BELMONT RECEIVED MIR REFERENCE NUMBER (B)(4) ON (B)(6) 2024 WHICH DETAILED THE FOLLOWING: DURING PRIMING OF SET, WATER LEAKED OUT OF THE ONE-WAY CHECK VALVE. SET REMOVED FROM USE AND REPLACED. NEW SET WORKING CORRECTLY. NOTE THAT THE MIR INCORRECTLY DETAILED THE LOT NUMBER INVOLVED AS (B)(6) 2012. THE LOT NUMBER INVOLVED WAS SUBSEQUENTLY CONFIRMED AS (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20422921 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Device Emits Odor; Temperature Problem; Fluid/Blood Leak; Device Emits Odor; Temperature Problem

  THE USER FACILITY REPORTED THE FOLLOWING: WE HAD TWO REPORTS INCIDENTS OF BELMONT MALFUNCTION. ONE IN THE ED AND ONE IN THE OR WITH LEAKING TUBING AND TOO HOT TO TOUCH WHEN THEY OPENED THE CHAMBER. "BELMONT TUBING RUPTURED WITH BLOOD LEAKING FROM THE HOUSING AND AN ELECTRICAL SMELL. WHEN I REMOVED THE TUBING FROM THE PUMP THE RING WAS VERY HOT." "I LATER LEARNED THAT THERE WAS SIMILAR INCIDENT IN THE ED WITH BELMONT TUBING RUPTURING. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410652 ↗
• MalfunctionOct 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE USER FACILITY REPORTED THE FOLLOWING: WE HAD TWO REPORTS INCIDENTS OF BELMONT MALFUNCTION. ONE IN THE ED GIVING ERROR MESSAGE AND ONE IN THE OR WITH LEAKING TUBING AND TOO HOT TO TOUCH WHEN THEY OPENED THE CHAMBER. THE USER FACILITY REPORTED THAT THE FIRST BELMONT AFTER A COUPLE UNITS (I CANNOT REMEMBER THE EXACT AMOUNT) GAVE AN ERROR MESSAGE. WE SWITCHED TO ANOTHER PRE-PRIMED BELMONT AND STARTED TRANSFUSING. "BELMONT TUBING RUPTURED WITH BLOOD LEAKING FROM THE HOUSING AND AN ELECTRICAL SMELL. WHEN I REMOVED THE TUBING FROM THE PUMP THE RING WAS VERY HOT." NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THIS INCIDENT. "I LATER LEARNED THAT THERE WAS SIMILAR INCIDENT IN THE ED WITH BELMONT TUBING RUPTURING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410457 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE ADMINISTERING A MAJOR HAEMORRHAGE PROTOCOL (MHP), 2 BAGS OF BLOOD WERE SUCCESSFULLY TRANSFUSED AND THE SET-UP LOOKED OKAY. HOWEVER, WHEN TRANSFUSING THE THIRD BAG OF BLOOD IT WAS NOTED THAT BLOOD WAS LEAKING THROUGH THE DOOR? THE REPORTER WAS UNCERTAIN OF THE SOURCE OF THE LEAKAGE, BUT A SLIGHT GAPING WAS OBSERVED ON THE DOOR. THE INITIAL DEVICE WAS REPLACED AND THE REPLACEMENT DEVICE USED WITH THE SAME PROTOCOL ADMINISTERED AS PER PLAN AND PATIENT NEED. NO PATIENT HEALTH IMPACT OR CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811684 ↗
• MalfunctionJul 23, 2024

  DURING MTP (MASSIVE TRANSFUSION PROTOCOL) THE BELMONT HEATING ELEMENT/FILTER BURNED THROUGH AND STARTED LEAKING BLOOD ONTO THE FLOOR. THIS WAS AT OR ABOUT BLOOD PRODUCT NUMBER 32. THERE WAS A BLACKENED AREA TO THE RING. ELECTRICAL BURNING SMELL WAS ALSO PRESENT. THE BELMONT RAPID TRANSFUSER WAS FOUND TO HAVE NO MALFUNCTION. TUBING MALFUNCTION SUSPECTED.

  Patient problems: Insufficient Information

  MAUDE report 19804537 ↗
• MalfunctionApr 26, 2024Material Separation; Connection Problem; Material Separation; Connection Problem

  THE USER FACILITY REPORTED THAT AT BAY A3 USING BELMONT RAPID INFUSER TO ADMINISTER BLOOD RAPIDLY TO A PATIENT WHO WAS IN CRITICAL CONDITION, HAD AN ALARM TO RE PRIME, WHICH WAS DONE, THEN DURING TRANSFUSION IT APPEARS A PLASTIC PEG POPPED OUT, AND BLOOD SPRAYED ALL OVER, AND UNIT NO LONGER FUNCTIONING, STAFF HAD TO QUICKLY PRIME ANOTHER UNIT AND GET ANOTHER UNIT OF BLOOD TO GIVE TO THIS PATIENT WHO WAS IN CRITICAL CONDITION, NEEDING BLOOD QUICKLY, PATIENT UNABLE TO GET 1ST UNIT, AS IT SPRAYED ALL OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192019 ↗
• MalfunctionMar 13, 2024Material Separation; Connection Problem; Material Separation; Connection Problem

  BELMONT RECEIVED MIR REFERENCE NUMBER: (B)(4). WHICH DETAILED THE FOLLOWING INCIDENT. SEAL BROKEN AROUND SPIKE, UNABLE TO DISCONNECT EMPTY UNIT OR REATTACH MORE UNITS. OCCURRED ON TWO SPIKES DURING MASSIVE TRANSFUSION PROTOCOL. THERE IS NO INDICATION OF ANY PATIENT HARM OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899558 ↗
• MalfunctionJan 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE RISK MANAGER REPORTED THAT WHILE USING THE BELMONT, THE TUBING WAS REPORTED AS BROKEN WHILE INFUSING BLOOD PRODUCTS AND "SPILLING" OUT OF THE TOP OF THE CANISTER. THERE IS NO REPORT OF ANY PATIENT HARM ASSOCIATED WITH THIS INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 18515272 ↗
• MalfunctionJan 15, 2024Material Separation; Material Separation

  DURING A MASSIVE TRANSFUSION EVENT USING BELMONT TUBING, ONE OF THE SPIKES FROM THE Y-SITE BROKE OFF INTO THE BAG OF BLOOD WHEN THE BAG WAS SPIKED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515262 ↗
• MalfunctionOct 31, 2023Leak/Splash; Leak/Splash

  THE DISTRIBUTOR REPORTED THAT DURING A CASE, BELMONT WAS USED FOR TRANSFUSION. AFTER TWO BAGS OF SAG AND TWO BAGS OF PLASMA, THEY NOTICED THAT FLUID WAS LEAKING FROM THE LARGE CHAMBER. AS A PART OF IMMEDIATE ACTION, CHECKED IF THE VALVE WAS TOO LOOSE, AND IF THERE WERE ANY VISIBLE CRACKS IN THE CHAMBER, BUT I COULDN'T SEE ANYTHING. COULDN'T LOCATE WHERE THE LEAK WAS COMING FROM. GOT THE REST OF THE TRANSFUSION IN (NOT A FAULT WITH THE MACHINE, BUT WITH THE SET). DISCONNECTED THE ENTIRE SYSTEM AND USED RANGER FOR THE NEXT TWO BAGS OF SAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038044 ↗
• MalfunctionAug 17, 2023Connection Problem; Connection Problem

  THE USER FACILITY REPORTED THAT SPIKES DETACHED ON TWO DIFFERENT 3-SPIKE DISPOSABLES DURING THE SAME MASSIVE PROCEDURE. THE SPIKES FELL OUT OF THE BLOOD BAGS, AFTER WHICH DISPOSABLE WAS PRIMED AND USED FOR ADMINISTERING BLOOD SINCE THE PATIENT WAS UNSTABLE, IT WAS NOT FULLY DISCONNECTED AND RE-PRIMED. HOWEVER, AFTER SOME TIME THAT SPIKE FELL OUT WHICH WAS THEN REPLACED WITH NEW SET OF TUBING. THE NEW DISPOSABLE SET WAS PRIMED AND USED FOR THE PROCEDURE WHICH GOT DETACHED WHILE CHANGING THE BLOOD BAG. ALTHOUGH THE PATIENT INVOLVED IN THE PROCEDURE EXPIRED, IT WAS DETERMINED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH AS A NEW SET WAS ABLE TO BE PRIMED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568402 ↗
• MalfunctionAug 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT RECEIVED MHRA (UK) REPORT (B)(4), WHICH DETAILED THAT THE 3 SPIKE DISPOSABLE SET WAS LEAKING. A PHOTOGRAPH WAS PROVIDED THAT INDICATES A CLAIMED POSITION OF A LEAK HOWEVER NO LEAK IS ACTUALLY EVIDENT ON THE PHOTOGRAPH. NO PATIENT INJURY IS INDICATED AND NO LOT NUMBER WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17568304 ↗
• MalfunctionJun 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE DISTRIBUTOR REPORTED THAT THE DISPOSABLE LEAKED DURING A CASE. NO LOT# IS AVAILABLE BUT THE SET WAS SAVED AND WILL BE SENT BACK FOR INVESTIGATION. THE PATIENT REPORTEDLY EXPIRED IN THIS EVENT BUT, IT WAS STATED BY THE DISTRIBUTOR THAT THE DEATH WAS NOT ATTRIBUTED TO THE REPORTED ISSUE WITH THE DISPOSABLE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140082 ↗

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 (