Alaris 72215NRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10885403235467), received between Jul 16, 2019 and Jan 14, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Delivered as Unsterile Product

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073941 ↗
• MalfunctionSep 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ADAPTOR IS ON AS TIGHT AS CAN BE AND IT IS LEAKING FROM THE BLUE SPIN COLLAR PORTION OF THE OPTIMA ADAPTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057140 ↗
• MalfunctionJun 2, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127027 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE HUB OF THE PRIMARY TUBING DOES NOT CONNECT WELL TO THE THREAD ON THE SECONDARY TUBING. THE CONNECTION COMES APART AND CAUSES MEDICATION AND BLOOD TO GO TO THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554711 ↗
• MalfunctionMar 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543455 ↗
• MalfunctionDec 5, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS UNDER INFUSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM SECONDARY SET 72215N USED TO INFUSE IVIG ON 3 PATIENTS. EVEN WHEN USING 2 HANGERS TO LOWER PRIMARY LINE THE PRIMARY LINE WAS STILL INFUSING CONCURRENTLY WITH SECONDARY. THIS RESULTED IN LONGER INFUSION TIME FOR IVIG. THIS OCCURED DURING INFUSION RATES RANGING FROM 43ML/H 180ML/H.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853461 ↗
• MalfunctionJun 10, 2024Partial Blockage; Complete Blockage; Partial Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507157 ↗
• MalfunctionMay 4, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SECONDARY SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE APPEARS TO BE NO COMMUNICATION BETWEEN THE CHAMBER UNDER THE SPIKE TO THE LINE- FLUID CANNOT RUN DOWN THE LINE. THEY HAVE BEEN HAVING ONGOING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873452 ↗
• MalfunctionJan 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ SECONDARY SET TUBING FELL OFF THE BOTTOM OF THE DRIP CHAMBER WHEN THE PENICILLIN SECONDARY INFUSION WAS STARTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER THE RN BEGAN THE SECONDARY INFUSION, SHE WAS PUTTING A STICKER ON THE DRIP CHAMBER AND THE TUBING FELL OFF OF THE BOTTOM OF THE DRIP CHAMBER. THE MEDICATION HAD JUST BEEN STARTED, SO IT HAD NOT REACHED THE PATIENT. A NEW SET OF SECONDARY TUBING AND A NEW DOSE OF MEDICATION WAS OBTAINED AND STARTED WITH NO ISSUES. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PT WAS TO BE GIVEN A DOSE OF PENICILLIN AS A SECONDARY INFUSION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251583 ↗
• MalfunctionJul 1, 2022Backflow; Complete Blockage; Improper Flow or Infusion; Backflow; Complete Blockage; Improper Flow or Infusion

  IT WAS REPORTED THAT SEVERAL BD ALARIS SECONDARY SET EXPERIENCED FLOW ISSUE, OCCLUSION AND CHECK VALVE MALFUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICIANS REPORT VANCOMYCIN AND KPHOS INFUSIONS RUNNING SLOWER THAN INTENDED. BOTH MEDICATIONS ARE INFUSED ON A PRIMARY LINE. CLINICIANS REPORT CHEMOTHERAPY INFUSIONS EITHER FINISH SOONER THAN EXPECTED OR LATER THAN EXPECTED. MCKINLEY OUTPATIENT CENTER IS ALSO HAVING ISSUES WITH INFUSION RATE ACCURACY ¿BUT NOT AS MANY¿. SOMETIMES THE LINE WILL RUN DRY AND THEY WILL BE UNABLE TO COMPLETE THE INFUSION. THEN THEY DO NOT KNOW HOW MUCH DRUG THE PATIENT RECEIVED OR THE TRUE END TIME OF THE INFUSION. MOST CLINICIANS REPORT THEY HAVE ALL HAD ISSUES WITH INFUSIONS NOT ENDING ON TIME AND WITH THE VOLUME OF THE BAG NOT MATCHING THE VOLUME INFUSED ON THE PUMP. A CLINICIAN REPORTED THAT THE VOLUME ON THE PUMP IS ALWAYS ¿OVER¿ FOR EXAMPLE, IF THEY HAD A 100ML BAG WITH THEIR OLD PUMPS, IT WOULD ALWAYS BE 100ML-101ML. BUT NOW, THE TOTAL VOLUME WILL SAY 108ML OR 111ML AT THE END OF THE INFUSION. ANOTHER CLINICIAN STATED THAT YESTERDAY (5/31/22) SHE STARTED A TITRATED INFUSION AT 100ML/HR OVER 30 MINUTES, BUT IT TOOK 5 AD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14893880 ↗
• MalfunctionJul 1, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT SEVERAL BD ALARIS SECONDARY SET EXPERIENCED AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN, STATED THAT YESTERDAY SHE HAD A DEVICE ALARMING AIL WITH NO AIR-IN-LINE. CRU REPORTS RECEIVING PREPARED IV BAGS/PRIMED IV LINES FROM PHARMACY WITH AIR IN THEM AND HAVE HAD ISSUES WITH AIL ALARMS. CLINICIAN REPORTS THAT THE ALARIS SYSTEM IS ¿VERY SENSITIVE¿ TO AIL AND THAT WITH BBRAUN IT WAS ¿NOT MUCH OF AN ISSUE¿. CLINICIAN ALSO REPORTS THAT THE TEXIUM CONNECTION ON THEIR SECONDARY SET ¿HOLDS AIR¿, AND SO FOR SECONDARY INFUSIONS THEY HAVE TO WAIT AT THE PUMP WHEN THEY START THE INFUSION BECAUSE THEY WILL OFTEN GET AIL ALARMS 30 SECONDS AFTER STARTING AN INFUSION. ANOTHER CLINICIAN STATES THAT IT IS BECAUSE THEY CANNOT PRIME THROUGH THE TEXIUM THAT IS CAUSING THIS AIL ISSUE. A PATIENT REPORTED THAT WHAT HE LIKED BETTER ABOUT THE PREVIOUS BBRAUN PUMPS WAS THAT THEY HAD A WAY TO GET RID OF THE AIL, WHEREAS THE ALARIS PUMPS STOP THE INFUSION AND ALARMS, AND THEN THE ALARM NEEDS TO BE ADDRESSED BY A CLINICIAN. ANOTHER CLINICIAN ALSO STATES THAT SHE HAS ISSUES WITH AIL AND AIL MOVING PAST THE AIL SENSOR. CLINICIANS REPORT AIL ISSUES WITH CERTAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14893805 ↗
• MalfunctionAug 27, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SEC SET 15DP W/HANGER DEHP FREE EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SECONDARY TUBING BROKE BELOW CHAMBER WHEN MEDICATION SPIKED. NO MEDICATION SPILL NOTICED IMMEDIATELY. LINE HAD NOT BEEN PRIMED YET. ADDITIONAL INFORMATION (CUSTOMER RESPONSE) (B)(6) 2020: 1. WHAT WAS THE DATE AND TIME OF THE EVENT? (B)(6) 2020-TIME UNKNOWN. 2. WHAT WAS THE TUBING SET LOT NUMBER THAT WAS IN USE AT THE TIME OF THE EVENT? (10)20015721. 3. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/SETUP OR WHEN TAKEN OUT OF PACKAGE? DURING PREPARATION. 4. IF PATIENT INVOLVEMENT; WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT? NO PATIENT EFFECTS. 5. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: MINOR DELAY IN RECEIVING INFUSION.

  Patient problems: No Patient Involvement

  MAUDE report 10463650 ↗
• MalfunctionJul 24, 2020Break

  SECONDARY TUBING BROKE BELOW CHAMBER WHEN MEDICATION SPIKED. NO MEDICATION SPILL, NOTICED IMMEDIATELY. LINE HAD NOT BEEN PRIMED YET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10319582 ↗
• MalfunctionFeb 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WERE SECONDARY TUBING SETS THAT SEPARATED AT THE DRIP CHAMBER IN THE EMERGENCY DEPARTMENT. IT WAS A TOTAL OF FOUR SECONDARY TUBING SETS INVOLVED, ALL OCCURRING BEFORE PATIENT USE. ONE SET SEPARATED UPON PRIMING OF AN ANTIBIOTIC, ONE OCCURRED WHILE "UNCOILING" OUT OF PACKAGING , AND TWO OCCURRED UPON A "GENTLE TUG" WHEN REMOVING FROM PACKAGING. IT WAS REPORTED THAT THE EVENTS DID NOT CAUSE A DELAY THE SIGNIFICANTLY IMPACTED PATIENT CARE. THERE WAS NO HARM TO THE USER AS A RESULT OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9747849 ↗
• MalfunctionFeb 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WERE SECONDARY TUBING SETS THAT SEPARATED AT THE DRIP CHAMBER IN THE EMERGENCY DEPARTMENT. IT WAS A TOTAL OF FOUR SECONDARY TUBING SETS INVOLVED, ALL OCCURRING BEFORE PATIENT USE. ONE SET SEPARATED UPON PRIMING OF AN ANTIBIOTIC, ONE OCCURRED WHILE "UNCOILING" OUT OF PACKAGING , AND TWO OCCURRED UPON A "GENTLE TUG" WHEN REMOVING FROM PACKAGING. IT WAS REPORTED THAT THE EVENTS DID NOT CAUSE A DELAY THE SIGNIFICANTLY IMPACTED PATIENT CARE. THERE WAS NO HARM TO THE USER AS A RESULT OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9747691 ↗
• MalfunctionFeb 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WERE SECONDARY TUBING SETS THAT SEPARATED AT THE DRIP CHAMBER IN THE EMERGENCY DEPARTMENT. IT WAS A TOTAL OF FOUR SECONDARY TUBING SETS INVOLVED, ALL OCCURRING BEFORE PATIENT USE. ONE SET SEPARATED UPON PRIMING OF AN ANTIBIOTIC, ONE OCCURRED WHILE "UNCOILING" OUT OF PACKAGING , AND TWO OCCURRED UPON A "GENTLE TUG" WHEN REMOVING FROM PACKAGING. IT WAS REPORTED THAT THE EVENTS DID NOT CAUSE A DELAY THE SIGNIFICANTLY IMPACTED PATIENT CARE. THERE WAS NO HARM TO THE USER AS A RESULT OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9747689 ↗
• MalfunctionFeb 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WERE SECONDARY TUBING SETS THAT SEPARATED AT THE DRIP CHAMBER IN THE EMERGENCY DEPARTMENT. IT WAS A TOTAL OF FOUR SECONDARY TUBING SETS INVOLVED, ALL OCCURRING BEFORE PATIENT USE. ONE SET SEPARATED UPON PRIMING OF AN ANTIBIOTIC, ONE OCCURRED WHILE "UNCOILING" OUT OF PACKAGING , AND TWO OCCURRED UPON A "GENTLE TUG" WHEN REMOVING FROM PACKAGING. IT WAS REPORTED THAT THE EVENTS DID NOT CAUSE A DELAY THE SIGNIFICANTLY IMPACTED PATIENT CARE. THERE WAS NO HARM TO THE USER AS A RESULT OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9747688 ↗
• MalfunctionJan 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE PRIMING IV POTASSIUM, THE TUBING SEPARATED BELOW THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9574738 ↗
• MalfunctionAug 22, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT DURING A SECONDARY HYPERAL INFUSION THE SET DISCONNECTED FROM THE DRIP CHAMBER AND LEAKED. THE RN STATED THAT THE SET WAS IN USE FOR 24 HRS. WHEN THE EVENT OCCURRED. THE CUSTOMER CONFIRM THAT THERE WAS NO DELAY IN PATIENT TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8919522 ↗
• MalfunctionAug 13, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A SECONDARY ROCEPHIN INFUSION THE SET DISCONNECTED FROM THE DRIP CHAMBER AND LEAKED. THE RN STATED THAT THE SET WAS IN USE FOR LESS THAN 24HRS. THE CUSTOMER CONFIRMED THAT THERE WAS NO DELAY IN PATIENT TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890804 ↗
• MalfunctionJul 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORTED FEEDBACK SUGGESTS THAT THERE WAS A LEAKAGE OF CYTOTOXIC DRUGS. FROM THE REPORTED INFORMATION THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF CYTOTOXIC EXPOSURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793641 ↗