Alaris 10016073Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 10885403230110), received between Dec 13, 2018 and Sep 28, 2026 — classified as 99 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (28 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926167 ↗
• MalfunctionSep 28, 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 Verbatim.It was reported by the customer that the secondary tubing that did not infuse medication from the bag.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917199 ↗
• MalfunctionJun 10, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY GRAVITY SET HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALSO, THIS MORNING, SAME UNIT HAD AN ISSUE WITH THE SECONDARY TUBING. A PATIENT WAS SCHEDULED FOR IV TYLENOL AND HAD PRIMARY NS KVO INFUSION ALREADY ON THE ALARIS PUMP. THEY VERIFIED SET-UP AND SECONDARY TUBING UNCLAMPED AND HUNG ABOVE PRIMARY TUBING OF NS. THE ALARIS PUMP ALARMED THAT INFUSION WAS COMPLETE, BUT THE NURSE FOUND TYLENOL HAD NOT BEEN ADMINISTERED AND THE PUMP HAD PULLED THE VOLUME FROM THE NS. THEY DISCARDED THE SET AND STARTED NEW NS PRIMED WITH SECONDARY IV TYLENOL, MANUALLY CLAMPED THE PRIMARY NS BAG PRIOR TO ADMINISTERING THE IV TYLENOL. WITH THAT CLAMPING, THE SECONDARY INFUSION THEN RAN CORRECTLY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? IT HAS HAPPENED TWICE IN THE PAST WEEK. NEITHER OF THE SPECIFIC TUBING WAS SAVED, AND THE LOT NUMBER IS UNKNOWN. THIS WAS IN REFERENCE TO BD REF#10016073, SECONDARY TUBING SET. BELOW IS A SUMMARY OF THE INCIDENT: ¿PRIMARY RN HUNG IV TYLENOL AS SECONDARY INFUSION AS ORDERED. A FEW MINUTES LATER, THE ALARIS PUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461904 ↗
• MalfunctionJun 5, 2026Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY GRAVITY SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WAS ADMINISTERING IV CYTARABINE WHEN THE SECONDARY TUBING BROKE RIGHT BELOW THE DRIP CHAMBER. THE CHEMO HAD JUST STARTED AND HAD NOT YET REACHED THE PATIENT AS IT WAS STILL IN LOADING DOSE MODE. CHEMO BEGAN TO SPILL FROM THE BREAK AND LEAKED ONTO THE FLOOR AND DRIPPED ON RN¿S SCRUB PANTS. RN NOTIFIED CHARGE RN AND PROMPTLY BEGAN CLEANING WITH THE CHEMO SPILL KIT. CHEMO PHARMACY WAS PROMPTLY NOTIFIED TO MAKE A NEW BAG. FAULTY TUBING WAS SAVED FOR FURTHER EVALUATION. THIS HAS HAPPENED MORE THAN ONCE AND IS A CONCERN (WITH CHEMO AND THE TUBING). MY RUDIMENTARY EVALUATION IS THAT POSSIBLY, THE CHEMO IS TOO CAUSTIC FOR THE PLASTIC TUBING, OR THE TUBING IS NOT PLIABLE ENOUGH TO INFUSE WITH EASE, THUS THE PRESSURE BUILDS UP CAUSING THE BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411051 ↗
• MalfunctionJun 5, 2026Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY GRAVITY SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WAS ADMINISTERING IV CYTARABINE WHEN THE SECONDARY TUBING BROKE RIGHT BELOW THE DRIP CHAMBER. THE CHEMO HAD JUST STARTED AND HAD NOT YET REACHED THE PATIENT AS IT WAS STILL IN LOADING DOSE MODE. CHEMO BEGAN TO SPILL FROM THE BREAK AND LEAKED ONTO THE FLOOR AND DRIPPED ON RN¿S SCRUB PANTS. RN NOTIFIED CHARGE RN AND PROMPTLY BEGAN CLEANING WITH THE CHEMO SPILL KIT. CHEMO PHARMACY WAS PROMPTLY NOTIFIED TO MAKE A NEW BAG. FAULTY TUBING WAS SAVED FOR FURTHER EVALUATION. THIS HAS HAPPENED MORE THAN ONCE AND IS A CONCERN (WITH CHEMO AND THE TUBING). MY RUDIMENTARY EVALUATION IS THAT POSSIBLY, THE CHEMO IS TOO CAUSTIC FOR THE PLASTIC TUBING, OR THE TUBING IS NOT PLIABLE ENOUGH TO INFUSE WITH EASE, THUS THE PRESSURE BUILDS UP CAUSING THE BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411049 ↗
• MalfunctionMay 3, 2026Contamination; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE IV MEDICATION WAS PRECIPITATED IN THESE 2 TUBING SETS SPECIFICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062480 ↗
• MalfunctionApr 29, 2026Deformation Due to Compressive Stress; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE BD ALARIS GRAVITY SET HAD A KINK / BEND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITH IV SET DEMONSTRATION, NURSING NOT FOLLOWING ALL STEPS FOR PROPER IV SET LOADING. DRIP CHAMBERS SEEN FILLED LESS THAN 2/3 FULL. OBSERVED IV SETS STILL COILED DIRECTLY BELOW THE DRIP CHAMBER WHILE INFUSING. NURSING UNAWARE OF LOCATION OF AIR IN LINE SENSOR. PUMP MODULES DOOR LEFT OPEN FOLLOWING DISCONTINUED IVS WHEN RN DISCARDS TUBING AND IV CONTAINER. PRIMARY IV SET #2426-0007. SECONDARY IV SET #10016073.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036109 ↗
• MalfunctionApr 29, 2026Product Quality Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE BD ALARIS GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITH IV SET DEMONSTRATION, NURSING NOT FOLLOWING ALL STEPS FOR PROPER IV SET LOADING. DRIP CHAMBERS SEEN FILLED LESS THAN 2/3 FULL. OBSERVED IV SETS STILL COILED DIRECTLY BELOW THE DRIP CHAMBER WHILE INFUSING. NURSING UNAWARE OF LOCATION OF AIR IN LINE SENSOR. PUMP MODULES DOOR LEFT OPEN FOLLOWING DISCONTINUED IVS WHEN RN DISCARDS TUBING AND IV CONTAINER. PRIMARY IV SET #2426-0007. SECONDARY IV SET #10016073.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036090 ↗
• MalfunctionApr 27, 2026Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD AIR THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE SECONDARY INFUSION DELIVERY WITH REPORTED OBSERVATIONS OF REMAINING SECONDARY MEDICATION, THE PUMP PULLING FROM THE PRIMARY BAG, AND SIGNIFICANT CHEMOTHERAPY INFUSION DELAYS. NURSING AWARE OF LOCATION OF AIR IN LINE SENSOR, BUT STATED THEY DO EXPERIENCE AIR IN LINE ALARMS WELL INTO THE INFUSION WITH SOME OF THE MORE BUBBLY CHEMOTHERAPY INFUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008524 ↗
• MalfunctionApr 27, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE SECONDARY INFUSION DELIVERY WITH REPORTED OBSERVATIONS OF REMAINING SECONDARY MEDICATION, THE PUMP PULLING FROM THE PRIMARY BAG, AND SIGNIFICANT CHEMOTHERAPY INFUSION DELAYS. NURSING AWARE OF LOCATION OF AIR IN LINE SENSOR, BUT STATED THEY DO EXPERIENCE AIR IN LINE ALARMS WELL INTO THE INFUSION WITH SOME OF THE MORE BUBBLY CHEMOTHERAPY INFUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008512 ↗
• MalfunctionApr 23, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD ALARIS GRAVITY SET HAD FOREIGN MATTER IN THE PATHWAY. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT SECONDARY SET FOUND WITH BROWNISH-BLACK SPOTS ON DRIP CHAMBER. CONCERN FOR CONTAMINATION AND LACK OF STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974362 ↗
• MalfunctionApr 17, 2026Contamination /Decontamination Problem

  IT IS REPORTED, ALARIS TUBING, DARK SPOTS IN THE CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911591 ↗
• MalfunctionApr 6, 2026Material Discolored

  POST INVESTIGATION FINDINGS: FOREIGN MATTER-EMBEDDED IN THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792285 ↗
• MalfunctionApr 6, 2026Material Discolored

  POST INVESTIGATION FINDINGS IDENTIFIED, EMBEDDED FOREIGN MATTER WITHIN THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791168 ↗
• MalfunctionMar 18, 2026Backflow

  IT IS REPORTED FLOW ISSUES-BACKFLOW WITH BD SECONDARY SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626445 ↗
• MalfunctionMar 10, 2026Air/Gas in Device

  IT WAS REPORTED BY THE CUSTOMER THAT AIR BUBBLES WERE OCCURRING IN THE SECONDARY TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557963 ↗
• MalfunctionMar 3, 2026Contamination

  SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500982 ↗
• MalfunctionFeb 27, 2026Leak/Splash; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477159 ↗
• MalfunctionJan 27, 2026Failure to Disconnect

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY GRAVITY SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STAFF IS HAVING DIFFICULTY CONNECTING AND DISCONNECTING THE SPIKE FROM THE SMALLER MED BAGS THAT COME FROM PHARMACY. THIS IS CAUSING STAFF FRUSTRATION, RISK OF HARM WHEN THEY FINALLY GET THE SPIKE OUT AND THEY ARE FLAILING, AND WASTE AS THEY ARE OPTING TO JUST GET ANOTHER TUBING SET FOR EACH NEW BAG. THE SPIKE IS PUNCTURING THE IV BAG UPON INSERTION. DIFFICULTY REMOVING THE SPIKE FROM THE SMALLER MED BAGS. ONE INSTANCE OF THE SPIKE PUNCTURING THE IV BAG WHEN A PATIENT WAS IN TRANSPORT. THE SPECIFIC DATES OF OCCURRENCE ARE UNKNOWN. LOT NUMBER IS UNKNOWN. NO ADVERSE EVENTS AS A RESULT OF THE REPORTED ISSUES. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE PROVIDE A DETAILED DESCRIPTION OF THE REPORTED ISSUE: ¿THE SPIKE IS PUNCTURING THE IV BAG UPON INSERTION.¿ IS THIS NOT PART OF THE NORMAL PROCEDURE, OR DOES THIS INDICATE A PROBLEM? DURING THE NORMAL SPIKING PROCEDURE, THE SHARP SPIKE IS PUNCTURING THE BAG BEYOND JUST SPIKING INTO THE BAG AS NORMAL. ON A CALL LAST WEEK WITH THE CUSTOMER, WE REVIEWED STEPS TO HELP PREVENT THIS F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193234 ↗
• MalfunctionJan 27, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY GRAVITY SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STAFF IS HAVING DIFFICULTY CONNECTING AND DISCONNECTING THE SPIKE FROM THE SMALLER MED BAGS THAT COME FROM PHARMACY. THIS IS CAUSING STAFF FRUSTRATION, RISK OF HARM WHEN THEY FINALLY GET THE SPIKE OUT AND THEY ARE FLAILING, AND WASTE AS THEY ARE OPTING TO JUST GET ANOTHER TUBING SET FOR EACH NEW BAG. THE SPIKE IS PUNCTURING THE IV BAG UPON INSERTION. DIFFICULTY REMOVING THE SPIKE FROM THE SMALLER MED BAGS. ONE INSTANCE OF THE SPIKE PUNCTURING THE IV BAG WHEN A PATIENT WAS IN TRANSPORT. THE SPECIFIC DATES OF OCCURRENCE ARE UNKNOWN. LOT NUMBER IS UNKNOWN. NO ADVERSE EVENTS AS A RESULT OF THE REPORTED ISSUES. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE PROVIDE A DETAILED DESCRIPTION OF THE REPORTED ISSUE: ¿THE SPIKE IS PUNCTURING THE IV BAG UPON INSERTION.¿ IS THIS NOT PART OF THE NORMAL PROCEDURE, OR DOES THIS INDICATE A PROBLEM? DURING THE NORMAL SPIKING PROCEDURE, THE SHARP SPIKE IS PUNCTURING THE BAG BEYOND JUST SPIKING INTO THE BAG AS NORMAL. ON A CALL LAST WEEK WITH THE CUSTOMER, WE REVIEWED STEPS TO HELP PREVENT THIS F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193232 ↗
• MalfunctionJan 27, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY GRAVITY SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STAFF IS HAVING DIFFICULTY CONNECTING AND DISCONNECTING THE SPIKE FROM THE SMALLER MED BAGS THAT COME FROM PHARMACY. THIS IS CAUSING STAFF FRUSTRATION, RISK OF HARM WHEN THEY FINALLY GET THE SPIKE OUT AND THEY ARE FLAILING, AND WASTE AS THEY ARE OPTING TO JUST GET ANOTHER TUBING SET FOR EACH NEW BAG. THE SPIKE IS PUNCTURING THE IV BAG UPON INSERTION. DIFFICULTY REMOVING THE SPIKE FROM THE SMALLER MED BAGS. ONE INSTANCE OF THE SPIKE PUNCTURING THE IV BAG WHEN A PATIENT WAS IN TRANSPORT. THE SPECIFIC DATES OF OCCURRENCE ARE UNKNOWN. LOT NUMBER IS UNKNOWN. NO ADVERSE EVENTS AS A RESULT OF THE REPORTED ISSUES. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE PROVIDE A DETAILED DESCRIPTION OF THE REPORTED ISSUE: ¿THE SPIKE IS PUNCTURING THE IV BAG UPON INSERTION.¿ IS THIS NOT PART OF THE NORMAL PROCEDURE, OR DOES THIS INDICATE A PROBLEM? DURING THE NORMAL SPIKING PROCEDURE, THE SHARP SPIKE IS PUNCTURING THE BAG BEYOND JUST SPIKING INTO THE BAG AS NORMAL. ON A CALL LAST WEEK WITH THE CUSTOMER, WE REVIEWED STEPS TO HELP PREVENT THIS F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193230 ↗
• MalfunctionJan 27, 2026Leak/Splash; Obstruction of Flow

  IT WAS REPORTED THAT BD ALARIS GRAVITY SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE FLUID BLAST AND NOT RUNNING ALL THE WAY THRU THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192747 ↗
• MalfunctionJan 13, 2026Partial Blockage

  IT WAS REPORTED THAT BD ALARIS GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT MEDICATION ONLY INFUSES FOR A SHORT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060899 ↗
• MalfunctionJan 7, 2026Contamination

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF OPENED NEW PACKAGE AND SPOTS OF BROWN NOTICED THROUGHOUT THE DRIP CHAMBER. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? THE DATE THE SET WAS DISCOVERED WAS 09-18-2025. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. WHEN STAFF DISCOVERED POSSIBLE CONTAMINATED SET THE SECONDARY SET WAS NOT USED AND THEREFORE NO PT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987035 ↗
• MalfunctionJan 6, 2026Partial Blockage

  IT WAS REPORTED THAT BD ALARIS GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT MEDICATION ONLY INFUSES FOR A SHORT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981441 ↗