Alaris, SmartSite 2477-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 07613203019460), received between Jul 18, 2018 and Sep 22, 2026 — classified as 2 injuries, 293 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (102 reports).

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

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. Aug 19, 2026Class IOpen, Classified

   Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

   Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. May 6, 2019Class ITerminated

   An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

   Z-1770-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 295 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860944 ↗
• MalfunctionSep 21, 2026Break

  It was reported that the BD Alaris SmartSite Pump Infusion Set was damaged.The following information was provided by the initial reporter: When unclamping the blood to run it through the line, the tubing broke and sprayed blood on the IV pole, floor, and on the primary nurse. We quickly stopped the spray and replaced with new tubing. The manager was notified. Employee health was notified. The nurse showered and put on new scrubs.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835117 ↗
• MalfunctionAug 26, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50462631 ↗
• MalfunctionAug 26, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50462630 ↗
• MalfunctionAug 20, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50348936 ↗
• MalfunctionAug 20, 2026Leak/Splash

  It was reported that BD alaris smartsite pump infusion set was leaking.The following information was received by the initial reporter with the following VerbatimIt was reported by the customer that IV blood tubing was connected to patient in preparation for blood product transfusion. While waiting for an independent double check, IV module alerted air in line. While clearing air from IV line, clinical staff noticed a significant leak from the bottom of drip chamber at the connection point with the tubing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50335070 ↗
• MalfunctionJul 6, 2026Backflow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WAS COMPLETING INFUSION RATE VERIFICATION DURING THE IDC PROCESS WITH PRIMARY RN FOR PRBC TRANSFUSION WHEN PRIMARY RN NOTED THAT BLOOD WAS BACK FLOWING INTO SECOND SPIKE THAT WAS CLAMPED WHILE PRIMING TUBING, THIS RN WATCHED THE RN CONFIRM THE CLAMP WAS FULLY ENGAGED, THIS RN WAS ALSO PRESENT IN THE ROOM DURING TUBING PRIMING AND OBSERVED THE CLAMP BEING PLACED. BOTH RNS BEGAN THE TRANSFUSION AND WATCHED TO SEE IF MORE BLOOD WOULD BACK FLOW INTO SECOND SPIKE. BLOOD DID CONTINUE TO BACK FLOW. RN SWITCHED BLOOD TUBING, MOVED CLAMP LOWER ON SECOND SPIKE. TRANSFUSION CONTINUED WITHOUT AND FURTHER ISSUES. RN DID NOTE THAT BOTH THE FIRST SET OF TUBING THAT BACK FLOWED AND SECOND SET OF TUBING THAT DID NOT HAVE ANY ISSUES HAD THE SAME LOT NUMBER. PRODUCT: ALARIS PUMP TUBING WD #: (B)(4) - TUBING BLOOD ADMINISTRATION 100IN SMARTSITE 15 GTT/ML 180UM MFG#: 2477-0007 LOT#: N/A PATIENT HARM: NO HARM EVIDENT, PHYSICAL OR OTHERWISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717265 ↗
• MalfunctionJul 2, 2026Backflow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD Y-TUBING PRIMED WITH SALINE FIRST. THEN CONNECTED BLOOD UNIT BAG TO SECOND Y PORT. BLOOD INFUSION STARTED ON ALARIS IV PUMP. WHEN CHECKING INFUSION AFTER A FEW MINUTES, BLOOD HAD BACK UP AND WAS LEAKING OUT OF THE HOLE WHERE THE SALINE Y TUBING HAD FALLEN OFF. UNIT OF BLOOD HAD TO BE WASTED AND DELAYED PT RECEIVING TRANSFUSION FOR GI [GASTROINTESTINAL] BLEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692215 ↗
• MalfunctionJul 2, 2026Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD Y-TUBING PRIMED WITH SALINE FIRST. THEN CONNECTED BLOOD UNIT BAG TO SECOND Y PORT. BLOOD INFUSION STARTED ON ALARIS IV PUMP. WHEN CHECKING INFUSION AFTER A FEW MINUTES, BLOOD HAD BACK UP AND WAS LEAKING OUT OF THE HOLE WHERE THE SALINE Y TUBING HAD FALLEN OFF. UNIT OF BLOOD HAD TO BE WASTED AND DELAYED PT RECEIVING TRANSFUSION FOR GI [GASTROINTESTINAL] BLEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692212 ↗
• MalfunctionJul 1, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE BLOOD ADMINISTRATION SET WAS PULLING FROM THE SALINE BAG AT THE SAME TIME AS THE BLOOD BAG DESPITE THE CLAMP BEING ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686104 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT WHILE RECEIVING A BLOOD TRANSFUSION, THE RN ENTERED THE ROOM TO FIND BLOOD DRIPPING ONTO THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340962 ↗
• MalfunctionMay 20, 2026Free or Unrestricted Flow

  THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT : I AM WRITING TO BRING TO YOUR ATTENTION THREE SEPARATE INCIDENTS RECENTLY IDENTIFIED BY MY TEAM INVOLVING THE FOLLOWING PRODUCT: INFUSION SET ¿ ALARIS PRIMARY, DUAL SPIKE BLOOD, 180 MICRON FILTER, WITH 1 SMARTSITE NEEDLE-FREE PORT. IT WAS OBSERVED THAT ONE OF THE DUAL SIDE CLAMPS WAS NOT FULLY SECURED EVEN THOUGH CLAMP HAS APPLIED. THIS RESULTED IN THE FLUID BAG EMPTYING PREMATURELY AT THE END OF THE TRANSFUSION. WE ARE CURRENTLY IN THE PROCESS OF IDENTIFYING THE SPECIFIC LOT/BATCH INVOLVED. IN THE MEANTIME, I WOULD LIKE TO ASK WHETHER YOUR TEAM IS AWARE OF ANY SIMILAR INCIDENTS OR REPORTS FROM OTHER SITES THAT MAY BE RELATED. PLEASE LET ME KNOW IF YOU REQUIRE ANY FURTHER DETAILS FROM OUR END.

  Patient problems: Insufficient Information

  MAUDE report 25232469 ↗
• MalfunctionMay 20, 2026Free or Unrestricted Flow

  THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT : I AM WRITING TO BRING TO YOUR ATTENTION THREE SEPARATE INCIDENTS RECENTLY IDENTIFIED BY MY TEAM INVOLVING THE FOLLOWING PRODUCT: INFUSION SET ¿ ALARIS PRIMARY, DUAL SPIKE BLOOD, 180 MICRON FILTER, WITH 1 SMARTSITE NEEDLE-FREE PORT. IT WAS OBSERVED THAT ONE OF THE DUAL SIDE CLAMPS WAS NOT FULLY SECURED EVEN THOUGH CLAMP HAS APPLIED. THIS RESULTED IN THE FLUID BAG EMPTYING PREMATURELY AT THE END OF THE TRANSFUSION. WE ARE CURRENTLY IN THE PROCESS OF IDENTIFYING THE SPECIFIC LOT/BATCH INVOLVED. IN THE MEANTIME, I WOULD LIKE TO ASK WHETHER YOUR TEAM IS AWARE OF ANY SIMILAR INCIDENTS OR REPORTS FROM OTHER SITES THAT MAY BE RELATED. PLEASE LET ME KNOW IF YOU REQUIRE ANY FURTHER DETAILS FROM OUR END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231987 ↗
• MalfunctionMay 20, 2026Excess Flow or Over-Infusion; Free or Unrestricted Flow

  THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM WRITING TO BRING TO YOUR ATTENTION THREE SEPARATE INCIDENTS RECENTLY IDENTIFIED BY MY TEAM INVOLVING THE FOLLOWING PRODUCT: INFUSION SET ¿ ALARIS PRIMARY, DUAL SPIKE BLOOD, 180 MICRON FILTER, WITH 1 SMARTSITE NEEDLE-FREE PORT. IT WAS OBSERVED THAT ONE OF THE DUAL SIDE CLAMPS WAS NOT FULLY SECURED EVEN THOUGH CLAMP HAS APPLIED. THIS RESULTED IN THE FLUID BAG EMPTYING PREMATURELY AT THE END OF THE TRANSFUSION. WE ARE CURRENTLY IN THE PROCESS OF IDENTIFYING THE SPECIFIC LOT/BATCH INVOLVED. IN THE MEANTIME, I WOULD LIKE TO ASK WHETHER YOUR TEAM IS AWARE OF ANY SIMILAR INCIDENTS OR REPORTS FROM OTHER SITES THAT MAY BE RELATED. PLEASE LET ME KNOW IF YOU REQUIRE ANY FURTHER DETAILS FROM OUR END.

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

  MAUDE report 25231983 ↗
• MalfunctionMay 8, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT AFTER SPIKING THE LAST BAG, STEM CELLS WERE NOT PULLING OUT FROM THE BAG VIA TUBING, SO STEM CELLS WERE INFUSED VIA INTRAVENOUS PUSH FROM THE 8TH BAG. TOTAL INFUSION TIME TOOK 16 MINUTES FOR THE 8TH BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128221 ↗
• MalfunctionMay 7, 2026Backflow

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT AFTER TUBING PRIMED AND STEM CELL PRODUCT BAG SPIKED, CELLS WOULD NOT ADVANCE INTO FILTER CHAMBER. FLUID FROM SECOND ARM FLOWED INTO FILTER CHAMBER DESPITE BEING CLAMPED. ADDITIONAL CLAMP APPLIED TO SECOND ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117211 ↗
• MalfunctionMay 7, 2026Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT AFTER TUBING PRIMED AND STEM CELL PRODUCT BAG SPIKED, CELLS WOULD NOT ADVANCE INTO FILTER CHAMBER. FLUID FROM SECOND ARM FLOWED INTO FILTER CHAMBER DESPITE BEING CLAMPED. ADDITIONAL CLAMP APPLIED TO SECOND ARM AND FILTER CHAMBER COLLAPSED WHEN ATTEMPTED TO OPEN STEM CELL ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117210 ↗
• MalfunctionApr 29, 2026Break; Fluid/Blood Leak; Separation Failure

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GOOD MORNING WE HAD AN INCIDENT WITH THE BELOW ITEM REF (B)(4). AT SHIFT CHANGE, PRIMARY RN WENT INTO ROOM TO ASSESS PATIENT'S HIGH BLOOD PRESSURE. A POOL OF BLOOD WAS ON THE GROUND FROM THE UNIT OF BLOOD THAT WAS INFUSING. PRIMARY RN ASSESSED THE TUBING AND SAW THAT PART OF THE TUBING BROKE AND SPILLING INTO THE IV CHANNEL AND ONTO THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037141 ↗
• MalfunctionApr 21, 2026Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING DEFECTIVE. IT WAS REPORTED BY THE TECH THAT IT FELL APART WHEN THEY TRIED TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947622 ↗
• MalfunctionApr 21, 2026Contamination

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT # - 2477-0007. LOT # - UNKNOWN. DESCRIPTION - BLACK SPOT ON TIP OF SPIKE. NO PATIENT HARM ¿ THIS WAS NOTICED BEFORE BEING PLACED ON A PATIENT AND NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942528 ↗
• MalfunctionMar 24, 2026Leak/Splash

  IT IS REPORTED, LEAK ABOVE THE FILTERED DRIP CHAMBER ON THE SALINE LINE. THIS WAS APPROXIMATELY 15 MINS INTO THE INFUSION. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681773 ↗
• MalfunctionMar 23, 2026Leak/Splash

  IT IS REPORTED ALARIS SMARTSITE, LEAK FROM THE PUMP SEGMENT TO THE SAFETY CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662050 ↗
• MalfunctionMar 13, 2026Backflow; Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD TWO 2477-0007 THAT HAVE BACKED UP BLOOD AND LEAKED IN THE UNUSED Y SPIKE THAT WAS CLAMPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597963 ↗
• MalfunctionMar 11, 2026Backflow; Improper Flow or Infusion; Infusion or Flow Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570962 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING BROKE AT CLAMP SITE ON BLOOD TUBING DURING INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477054 ↗