Alaris, SmartSite 41173ERecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613203020893), received between Aug 12, 2019 and Jul 24, 2025 — classified as 1 death, 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Free or Unrestricted Flow” (3 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT BD ALARIS GRAVITY SET WAS LOOSE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM.   IT WAS REPORTED BY CUSTOMER THAT WHEN THE GRAVITY TUBING WAS BEING PRIMED WITH NORMAL SALINE, THE BEDSIDE THEY NOTED AN UNUSUALLY SLOW DRIP RATE, WHICH DID NOT IMPROVE WITH COMPLETELY OPENING THE ROLLER CLAMP. (THERE NEEDS TO BE FREE FLOW OF FLUID THROUGH THIS TUBING WHEN STEM CELLS ARE INFUSING TO AVOID CLUMPING OF CELLS OR OTHER ADVERSE EFFECTS.) THIS TUBING WAS DISCARDED AND REPLACED WITH A NEW SET OF GRAVITY TUBING, WHICH DRIPPED APPROPRIATELY. PRODUCT INFORMATION: XX SMARTSITE GRAVITY SET, NEEDLE-FREE VALVE (VENTED/NONVENTED) REF 41173E (ALARIS PRODUCTS) LOT H37041173E1D (BOTH SETS OF GRAVITY TUBING USED WERE FROM THIS LOT.) DURING THE STEM CELL INFUSION, ONE SIDE OF THE SPIKE ADAPTER (A Y-SHAPED PIECE OF TUBING THAT IS USED TO SPIKE THE SMALL FLUID BAGS & THE STEM CELL BAGS) HAD ONE SIDE THAT WAS NOT CLAMPING. THE BEDSIDE THEY HAD TO USE A HEMOSTAT TO CLAMP THAT SIDE WHEN IT WAS NOT SUPPOSED TO BE DRIPPING. SPIKE ADAPTER - TWO SPIKES TO ONE SPIKE PORT WITH 20CM SCD TUBING AND PINCH CLAMPS REF 2S-P20 LOT V23644 THE STEM CELLS WERE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22598012 ↗
• MalfunctionJul 24, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT BD ALARIS GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT WHEN THE GRAVITY TUBING WAS BEING PRIMED WITH NORMAL SALINE, THE BEDSIDE THEY NOTED AN UNUSUALLY SLOW DRIP RATE, WHICH DID NOT IMPROVE WITH COMPLETELY OPENING THE ROLLER CLAMP. (THERE NEEDS TO BE FREE FLOW OF FLUID THROUGH THIS TUBING WHEN STEM CELLS ARE INFUSING TO AVOID CLUMPING OF CELLS OR OTHER ADVERSE EFFECTS.) THIS TUBING WAS DISCARDED AND REPLACED WITH A NEW SET OF GRAVITY TUBING, WHICH DRIPPED APPROPRIATELY. PRODUCT INFORMATION: XX SMARTSITE GRAVITY SET, NEEDLE-FREE VALVE (VENTED/NONVENTED) REF: 41173E (ALARIS PRODUCTS) LOT: H37041173E1D (BOTH SETS OF GRAVITY TUBING USED WERE FROM THIS LOT.) DURING THE STEM CELL INFUSION, ONE SIDE OF THE SPIKE ADAPTER (A Y-SHAPED PIECE OF TUBING THAT IS USED TO SPIKE THE SMALL FLUID BAGS & THE STEM CELL BAGS) HAD ONE SIDE THAT WAS NOT CLAMPING. THE BEDSIDE THEY HAD TO USE A HEMOSTAT TO CLAMP THAT SIDE WHEN IT WAS NOT SUPPOSED TO BE DRIPPING. SPIKE ADAPTER - TWO SPIKES TO ONE SPIKE PORT WITH 20CM SCD TUBING AND PINCH CLAMPS REF: 2S-P20, LOT: V23644 THE STEM CELLS WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22598004 ↗
• MalfunctionJan 2, 2024Backflow; Backflow

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD BACK FLOW THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: WE CONTINUE TO HAVE ISSUES WITH THE SMART SITE GRAVITY TUBING BACKFLOWING IN THE ED. REF # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18423452 ↗
• MalfunctionJun 14, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT PRIOR TO USE WITH BD ALARIS¿ SMARTSITE¿ GRAVITY SET THE ROLL CLAMP WAS DISCOVERED TO BE MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEALTH PROFESSIONAL CALLED IN TO REPORT THAT THE PRODUCT IS SUPPOSED TO COME WITH ROLL CLAMP BUT DID NOT HAVE ONE IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131247 ↗
• MalfunctionMar 27, 2023Backflow; Backflow

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALARIS¿ SMARTSITE¿ GRAVITY SETS BACK-FLOWED DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DESCRIBE THE EVENT OR PROBLEM: OUR IV TUBING GRAVITY ADMINISTRATION SET HAS BEEN BACK FLOWING EXCESSIVELY ON MULTIPLE PATIENTS OVER THE LAST WEEK. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : IV FLUIDS WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625104 ↗
• MalfunctionMar 27, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET'S IV TUBING SNAPPED OFF AND BROKE WHEN STARTING THE BAG OF IV FLUID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DESCRIBE THE EVENT OR PROBLEM: ... LAST NIGHT ONE OF THE IV TUBING SETS SNAPPED OFF AND BROKE WHEN A NURSE WAS STARTING A BAG OF FLUIDS. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : IV FLUIDS. WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625075 ↗
• MalfunctionMar 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET IS DAMAGED TEARING AT THE MIDLINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRAVITY TUBING IS TEARING MID LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16562357 ↗
• MalfunctionJul 29, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED COMPONENT SEPARATION, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: THE TUBING BROKE DURING STEM CELL INFUSION CREATING LOSS OF STEM CELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135555 ↗
• MalfunctionFeb 16, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET SEPARATED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "THE IV TUBING JUST FELL OFF OF THE DRIP CHAMBER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546443 ↗
• MalfunctionJan 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT BD ALARIS¿ SMARTSITE¿ GRAVITY SET HAD COMPONENTS SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PART NUMBER 2477-0007 A BLOOD SET LEAKING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358894 ↗
• MalfunctionOct 13, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET IV LINE WAS BLOCKED AND CAUSED REFLUX DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE FOUND THAT THE 41173E WAS CAUSING REFLUX AND CLOTTING OFF OUR IV LINES"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12626001 ↗
• MalfunctionDec 16, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEHPFREE PRI GRAV SET 1 SS VLV EXPERIENCED A MISSING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 41173E, BATCH NO: UNKNOWN, (REPORTED 20046883). I HAVE PRODUCT # 41173E, LOT # 20046883 GRAVITY SET WITH ROLLER CLAMP, WITH NO ROLLER CLAMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11024801 ↗
• InjuryOct 7, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT DEHPFREE PRI GRAV SET 1 SS VLV HAD AIR IN THE LINE WHICH LIKELY RESULTED IN AIR EMBOLISM. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 41173E BATCH NO: UNKNOWN . IT WAS REPORTED THAT CT OF CHEST/ABDOMEN/PELVIS REVEALED LIKELY A "IATROGENIC EMBOLISM" IN HEART AND PULMONARY ARTERIAL TRUNK. EVENT DESCRIPTION PER EMAIL STATES: CT CHEST/ABDOMEN/PELVIS REVEALED LIKELY IATROGENIC AIR EMBOLISM IN HEART AND PULMONARY ARTERIAL TRUNK. THIS IS THE SECOND SIMILAR EVENT IN A 2 MONTH TIME FRAME THAT COULD BE ATTRIBUTED TO IV TUBING. BD CURRENTLY HAS A RECALL ON OTHER IV TUBING THAT CAN RESULT IN AIR EMBOLISM. FDA SAFETY REPORT ID#(B)(4).

  Patient problems: Air Embolism

  MAUDE report 10646213 ↗
• InjuryJul 23, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT DEHPFREE PRI GRAV SET 1 SS VLV HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 41173E. BATCH NO.: UNKNOWN. IT WAS REPORTED THAT TWO EVENTS INVOLVING BD SMARTSITE GRAVITY SET OCCURRED. (B)(4). (B)(6) 2020 @ 1430. ((B)(6) OF AGE). GRAVITY SET IN USE IN ED SETTING WITH FLUIDS RUNNING AND ANOTHER MEDICATION GIVEN THROUGH PORT. PT WENT TO CT AND AIR EMBOLISM WAS NOTED IN HEART. A VERY SIMILAR EVENT OCCURRED A FEW WEEKS EARLIER IN SAME SETTING. THIS PT WAS SUBSEQUENTLY DISCHARGE. WE DON¿T KNOW FOR A FACT THAT THERE IS AN ISSUE BUT ARE CONCERNED WITH 2 VERY SIMILAR EVENTS IN A SHORT AMOUNT OF TIME. CUSTOMER RESPONSE 30-JUN-2020: 2 EVENTS, 1 PT EXPIRED, 1 PT WAS SAFELY DISCHARGED. WE DO NOT HAVE THE ORIGINAL PRODUCT TO RETURN.

  Patient problems: Air Embolism

  MAUDE report 10316699 ↗
• DeathJul 9, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT DEHPFREE PRI GRAV SET 1 SS VLV HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 41173E, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT TWO EVENTS INVOLVING BD SMARTSITE GRAVITY SET OCCURRED. CUSTOMER RESPONSE 07-JUL-2020: (B)(4). (B)(6) 2020 @ 1720. (B)(6). GRAVITY SET IN USE IN ED SETTING WITH FLUIDS RUNNING AND ANOTHER MEDICATION GIVEN THROUGH PORT. PT WENT TO CT AND AN AIR EMBOLISM WAS NOTED. PT. CODED AND EXPIRED LATER. WE DON¿T KNOW FOR A FACT THAT THERE IS AN ISSUE BUT ARE CONCERNED WITH 2 VERY SIMILAR EVENTS IN A SHORT AMOUNT OF TIME. CUSTOMER RESPONSE 30-JUN-2020: 2 EVENTS, 1 PT EXPIRED, 1 PT WAS SAFELY DISCHARGED. WE DO NOT HAVE THE ORIGINAL PRODUCT TO RETURN.

  Patient problems: Air Embolism

  MAUDE report 10253727 ↗
• MalfunctionAug 23, 2019Restricted Flow rate; Material Deformation; Restricted Flow rate; Material Deformation

  IT WAS REPORTED THAT THE DURING AN INFUSION OF NORMAL SALINE IN THE ED IT WAS FOUND THAT THE TUBING SET WAS KINKED AT THE Y-SITE. THE KINK WAS SIGNIFICANT ENOUGH THAT IT CONTINUALLY OCCLUDED THE FLOW TO THE PATIENT. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8927452 ↗
• MalfunctionAug 12, 2019Improper Flow or Infusion; Infusion or Flow Problem; Improper Flow or Infusion; Infusion or Flow Problem

  IT WAS REPORTED THAT SET WOULD NOT INFUSE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884765 ↗
• MalfunctionAug 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SET WOULD NOT FLUSH AND EVENTUALLY LEAKED FROM PORT. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884764 ↗