Alaris 10062818Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 07613203019668), received between Jul 16, 2018 and Sep 21, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 19, 2026Open, 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 · FDA record ↗

2. Oct 11, 2023Open, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0349-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that the BD Alaris SmartSite Gravity Set had damaged / defective tubing. The following information was provided by the initial reporter: Pt was receiving 1 unit of PRBCs, blood was started at rate of 120 ml/hr per protocol. RN returned to room for 15 min check, noticed blood was leaking out of the IV channel. Transfusion stopped, assessed bag, tubing and pt line for any leaks or disconnections. Hole was found in tubing where it is inserted into the pump channel. Blood tubing was changed, transfusion resumed without any further incident.Item Description: Set Infusion Iv Blood Non-Vented 180mcr Filter 122in Deph Fr.Intermountain Health #: (b)(6).MFG #: (b)(4).Lot #: 26035794.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842468 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775103 ↗
• MalfunctionSep 1, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50535437 ↗
• MalfunctionJun 18, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HUNG BLOOD USING CORRECT TUBING AND TECHNIQUES, INCLUDING PRIMING TUBING WITH NS. BLOOD BAG OPENED, AND NS BAG CLAMPED FOR ENTIRETY OF BLOOD TRANSFUSION. WHEN BLOOD BAG WAS EMPTY AND TUBING TO FILTER WAS EMPTY, BLOOD BAG WAS FIRMLY CLAMPED, AND THE NS BAG WAS OPENED. WHILE THE NS WAS FLUSHING THE TUBING, FLUID WAS PUSHED UP AND THROUGH THE BLOOD TUBING, IN ADDITION TO THROUGH THE MAIN TUBING TO THE PATIENT. THE FLUID THROUGH THE CLAMPED BLOOD BAG TUBING THEN BEGAN TO FILL THE BLOOD BAG. THIS RESULTED IN NOT ALL OF THE BLOOD BEING FLUSHED THROUGH THE TUBING IN THE DESIGNATED FOUR-HOUR WINDOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25550009 ↗
• MalfunctionJun 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE BLOOD INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTING QUALITY ISSUE WITH BLOOD ADMINISTRATION SET FOR BD TRACKING. TWO EVENTS OF SAME FAILURE 4/30/26 AND 5/1/26. LEAKING NOTED UPON SET UP FOR BLOOD PRODUCT ADMINISTRATION. LEAK NOTED AT CONNECTION OF WHITE PLASTIC BAG SPIKE AND THE BLOOD TUBING. NEW SET UP REQUIRED. RESULTED IN LOSS OF BLOOD PRODUCT AND REDUCTION OF VOLUME FOR PATIENT. PRODUCTS, PACKAGING, AND LOT NUMBERS NOT AVAILABLE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO INJURY TO PATIENTS. RESULTED IN DELAY OF TREATMENT FOR ONE PATIENT AND DISCONTINUATION OF TREATMENT FOR ANOTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477776 ↗
• MalfunctionJun 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE BLOOD INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTING QUALITY ISSUE WITH BLOOD ADMINISTRATION SET FOR BD TRACKING. TWO EVENTS OF SAME FAILURE (B)(6) 2026. LEAKING NOTED UPON SET UP FOR BLOOD PRODUCT ADMINISTRATION. LEAK NOTED AT CONNECTION OF WHITE PLASTIC BAG SPIKE AND THE BLOOD TUBING. NEW SET UP REQUIRED. RESULTED IN LOSS OF BLOOD PRODUCT AND REDUCTION OF VOLUME FOR PATIENT. PRODUCTS, PACKAGING, AND LOT NUMBERS NOT AVAILABLE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO INJURY TO PATIENTS. RESULTED IN DELAY OF TREATMENT FOR ONE PATIENT AND DISCONTINUATION OF TREATMENT FOR ANOTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477767 ↗
• MalfunctionFeb 12, 2026Leak/Splash; Material Puncture/Hole

  WHILE STARTING BLOOD ON THE PATIENT, BLOOD BEGAN DRIPPING FROM TUBING. PRIMARY RN NOTICED A HOLE IN THE TUBING. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328418 ↗
• MalfunctionDec 2, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT BD ALARIS 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 THREE EVENTS OF MALFUNCTION WITH THE BLOOD TUBING THIS PAST WEEK. SEEING FAILURE OF THE CLAMP BETWEEN THE SECOND BLUNT SPIKE AND THE DRIP CHAMBER CAUSING BLOOD TO BACKFLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695506 ↗
• MalfunctionDec 2, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT BD ALARIS 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 THREE EVENTS OF MALFUNCTION WITH THE BLOOD TUBING THIS PAST WEEK. SEEING FAILURE OF THE CLAMP BETWEEN THE SECOND BLUNT SPIKE AND THE DRIP CHAMBER CAUSING BLOOD TO BACKFLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695496 ↗
• MalfunctionDec 2, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT BD ALARIS 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 THREE EVENTS OF MALFUNCTION WITH THE BLOOD TUBING THIS PAST WEEK. SEEING FAILURE OF THE CLAMP BETWEEN THE SECOND BLUNT SPIKE AND THE DRIP CHAMBER CAUSING BLOOD TO BACKFLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695482 ↗
• MalfunctionSep 9, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION BLOOD SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM STARTED BLOOD ON PATIENT AND AT THE 15 MIN VITAL CHECK SAW THAT THE TUBING IN THE CHANNEL WAS SPLIT AND BLOOD WAS COVERING INCIDENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999791 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET SEPARATED, THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT "TREND OF A SPECIFIC BREAKAGE POINT ON SOME TUBING SETS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436909 ↗
• MalfunctionJul 8, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE LINE PULLING AIR NOTED FROM THE BAG TO THE PUMP LATER DURING INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435386 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE BLOOD LEAKED OUT OF CRACK OF CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367637 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE BLOOD STARTED LEAKING THROUGH THE CLAMPED PORT ONTO THE GROUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367636 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY HAD A CRACK IN THE BLOOD TUBING AT THE SPIKE END OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367635 ↗
• MalfunctionMay 6, 2025Backflow; Backflow

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE BLOOD INFUSION SET BACK FLOWED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NOTICED THAT MY BLOOD IN THE TUBING LOOKED SUPER DILUTED. I TRACED IT UP TO THE BAG AND THE BAG LOOKED OVERFILLED AND DILUTED BUT IF YOU TRACE THE TUBING CLOSER TO THE PATIENT IT DIDN'T LOOK DILUTED. I MADE SURE TO CHECK MY CLAMP ON MY NS SIDE AND THE CLAMP WAS IN PLACE AND DIDN'T APPEAR TO HAVE ANY ISSUES. I FINISHED WHAT WAS LEFT OF THE BLOOD AND PUT ON MY FLUSH AND A COUPLE MINS LATER I GO BACK IN BECAUSE IT IS BEEPING AIR IN LINE. SOMEHOW MY NS BAG RAN COMPLETELY DRY. SO, WHILE THE BLOOD WAS INFUSING, DESPITE BEING CLAMPED MY NS WAS BACK PRIMING INTO MY BLOOD BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970328 ↗
• MalfunctionMay 6, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE BLOOD INFUSION SET HAD A DEFECTIVE CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NOTICED THAT MY BLOOD IN THE TUBING LOOKED SUPER DILUTED. I TRACED IT UP TO THE BAG AND THE BAG LOOKED OVERFILLED AND DILUTED BUT IF YOU TRACE THE TUBING CLOSER TO THE PATIENT IT DIDN'T LOOK DILUTED. I MADE SURE TO CHECK MY CLAMP ON MY NS SIDE AND THE CLAMP WAS IN PLACE AND DIDN'T APPEAR TO HAVE ANY ISSUES. I FINISHED WHAT WAS LEFT OF THE BLOOD AND PUT ON MY FLUSH AND A COUPLE MINS LATER I GO BACK IN BECAUSE IT IS BEEPING AIR IN LINE. SOMEHOW MY NS BAG RAN COMPLETELY DRY. SO, WHILE THE BLOOD WAS INFUSING, DESPITE BEING CLAMPED MY NS WAS BACK PRIMING INTO MY BLOOD BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970326 ↗
• MalfunctionApr 24, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905985 ↗
• MalfunctionApr 24, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905984 ↗
• MalfunctionFeb 21, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18752162 ↗
• MalfunctionFeb 21, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD INFUSION SET CLAMP WAS DEFECTIVE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: ACTUAL: WHEN WE PRIMED AND HUNG BLOOD TUBING, WE CLAMPED THE LINES ABOVE THE BURETROL BEFORE WE CONNECTED THE TUBING TO THE PATIENT. WHEN WE BROUGHT THE BLOOD OVER TO THE ALARIS PUMP, WE NOTICED A FEW DROPS OF BLOOD THAT HAD FALLEN ONTO THE PUMP. WE DISCOVERED THE SOURCE OF THE LEAK APPEARS TO BE THAT ONE OF THE CLAMPS SLICED INTO THE BLOOD TUBING. GAP: SUPPLY FAILURE; TUBING WAS UNABLE TO BE CLAMPED WHILE REMAINING INTACT." THE PRODUCT WILL BE SAVED FOR 30 DAYS BEFORE BEING TOSSED. FOLLOW UP: 1. PLEASE PROVIDE THE DATE OF EVENT. 01/30/24 2. PLEASE ALSO PROVIDE US WITH THE FULL PICKUP ADDRESS, CONTACT NAME AND NUMBER, DEPARTMENT NAME, FLOOR NUMBER, AND ANY ADDITIONAL DETAILS SUCH AS (PICK UP AT RECEPTION, GOODS IN YARD, ETC.)? (B)(6) 3. CAN YOU PROVIDE A BATCH NUMBER? UNKNOWN 4. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? UNKNOWN 5. HAS THERE BEEN ANY PATIENT IMPACT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? UNKNOWN 1. IS THERE ANY PHYSICAL SAMPLE OR SAMPLE PHOTOS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751790 ↗
• MalfunctionOct 4, 2023Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED: MATERIAL#: 10062818. BATCH NUMBER#: 21115330. IT WAS REPORTED BY CUSTOMER THAT PLATELETS TO BE ADMINISTERED IN ROOM 698 - TUBING WAS PREPPED AND PLATELET BAG WAS SPIKED. UNCLEAR IF TUBING MALFUNCTION AND/OR BAG WAS SPIKED IMPROPERLY, BUT AFTER HANGING AND TRYING TO CLEAR LINE, TUBING DETACHED FROM BAG AND SOME CONTENTS SPILLED ONTO FLOOR AND PATIENT'S FOOT. PATIENT WAS UNHARMED AND CHECKED THROUGHOUT DAY. BLOOD BANK WAS CALLED AND CONFIRMED THAT TUBING/ BAG DID NOT NEED TO BE SAVED AS NO HARM CAME TO PATIENT. NEW PLATELETS WERE ACQUIRED AND REHUNG, AND PATIENT DID RECEIVED PLATELETS DURING SHIFT AS REQUIRED. VERBATIM#: RCC RECEIVED THE COMPLAINT VIA EMAIL. EMAIL(S) AS ATTACHED. ICARE: 293882 ¿PLATELETS TO BE ADMINISTERED IN ROOM 698 - TUBING WAS PREPPED AND PLATELET BAG WAS SPIKED. UNCLEAR IF TUBING MALFUNCTION AND/OR BAG WAS SPIKED IMPROPERLY, BUT AFTER HANGING AND TRYING TO CLEAR LINE, TUBING DETACHED FROM BAG AND SOME CONTENTS SPILLED ONTO FLOOR AND PATIENT'S FOOT. PATIENT WAS UNHARMED AND CHECKED THROUGHOUT DAY. BLOOD BANK WAS CALLED AND CONFIRMED THAT TUBING/ BAG DID NOT NEED TO BE SAVED AS NO HARM CAME TO PATIENT. NEW PLATELETS WERE ACQ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873247 ↗
• MalfunctionSep 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE GEM NV BLD SET W/180 FLT DEHP-FFP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PART#: 10062818 LOT#: 20025359 ISSUE: AFTER PLATELETS WERE SPIKED AND ADVANCED INTO THE FILTER CHAMBER, LEAKAGE WAS NOTED ABOVE THE FILTER ON THE PLATELET PORT. AS A RESULT, THE UNIT OF PLATELETS WERE DISCARDED AND A REPLACEMENT UNIT PREPARED. ¿ ARE YOU ABLE TO GIVE A SPECIFIC TIME FOR THIS INSTANCE THAT HAPPENED? NO, I DO NOT HAVE THE EXACT TIME. ¿ CAN YOU PROVIDE ANY PATIENT INFORMATION SUCH AS AGE, WEIGHT, DIAGNOSIS? NO, I CANNOT PROVIDE ANY PATIENT INFORMATION AS PER ORGANIZATION POLICY. WAS THE LINE HOOKED UP TO THE PATIENT YET BEFORE THE PROBLEM WAS NOTICED? YES, THE LINE WAS HOOKED UP TO THE PATIENT AND THE LEAK WAS NOTICED WHEN THE PLATELETS WERE ADVANCED INTO THE FILTER CHAMBER. ¿ WAS THE LINE INSERTED INTO ANY PUMP YET? YES ¿ I WANT TO BE SURE YOUR COMPLAINT IS ABOUT THE IV TUBING LINE RATHER THAN THE FILTER? THE COMPLAINT IS ABOUT THE CONNECTION BETWEEN THE IV TUBING AND THE FILTER WHICH IS EMBEDDED WITHIN THE LINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10564631 ↗
• MalfunctionJun 2, 2020Material Separation; Material Separation

  AN UNEXPECTED TUBING SET WAS RECEIVED AND IT APPEARED THE TUBING HAD SEPARATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 10113324 ↗