Alaris 10014916Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10885403233920), received between Oct 24, 2018 and Jun 2, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SYRINGE ADMINISTRATION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY EXPERIENCED CRACKING OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127853 ↗
• MalfunctionMay 29, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109887 ↗
• MalfunctionMar 14, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS¿ SYRINGE MODULE ADMINISTRATION SET WOULDN'T PRIME SALINE PAST THE FILTER AND CAUSED THE TUBING TO EXPAND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE A BD SYRINGE ADMIN SET, MICROBORE TUBING, WITH 0.2 MICRON LOW PROTEIN BINDING FILTER THAT WONT PRIME WITH SALINE. ONCE THE SALINE GETS TO THE PRESSURE DISC, IT JUST BLOWS THE DISK P LIKE A BALLOON AND WON'T PRIME PASSED THE DISK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541866 ↗
• MalfunctionFeb 10, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS¿ SYRINGE MODULE ADMINISTRATION SET HAD FLOW ISSUES AND WOULD NOT LET ANYTHING INFUSE BEYOND THE DISC DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS NOT AN EQUIPMENT MALFUNCTION. IT'S FOR THE SUPPLY MALFUNCTION. SYRINGE ADMIN SET WOULD NOT LET ANYTHING INFUSE BEYOND THE DISC THAT GETS PLACED ONTO THE PUMP. THE DISC WOULD BUBBLE UP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358483 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET LEAKED DURING A CONTINUOUS INFUSION OF DOPAMINE INFUSING GREATER THAN 24 HOURS AT A RATE OF 0.8-0.9ML/HOUR VIA THE PATIENT'S PICC LINE LOCATED IN THE INFANT PATIENT'S RIGHT FEMORAL ARTERY. THE DOPAMINE SYRINGE AND TUBING SET WAS REPLACED.

  Patient problems: No Information

  MAUDE report 8786895 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINUOUS INFUSION OF FENTANYL INFUSING AT A RATE OF 0.8ML/HOUR VIA THE INFANT PATIENTS BROVIAC CENTRAL LINE LOCATED IN THE PATIENT'S RIGHT FEMORAL ARTERY WHEN IT WAS NOTICED THAT THE PATIENTS BED LINENS WERE WET. UPON ASSESSMENT, THE NURSE FOUND THAT THE TUBING SET WAS WET. THE TUBING SET WAS DRIED ONLY TO FIND IT WET AGAIN.

  Patient problems: No Information

  MAUDE report 8786777 ↗
• MalfunctionJul 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE FILTER WHILE CONNECTED TO A PATIENT'S BRACHIAL PICC LINE. ALTHOUGH REQUESTED, THERE WERE NO FURTHER DETAILS OR INFORMATION PROVIDED AND NO REPORT OF HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8755415 ↗
• MalfunctionFeb 6, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK OCCURRED FROM A CRACK ON THE LUER OF THE SYRINGE PUMP TUBING WHILE INFUSING TPN IN THE NICU. THE LEAK OCCURRED AT THE CONNECTION BETWEEN THE 1 ML SYRINGE, TUBING, AND A NEEDLELESS CONNECTOR. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313692 ↗
• MalfunctionJan 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  PRODUCT RECEIVED UNEXPECTEDLY, THERE WAS A NOTE ATTACHED WITH THE RETURNED PRODUCT STATED; "DEFECTIVE, FILTER LEAKING. AN INCOMPLETE EVENT DATE DOCUMENTED ON THE NOTE AS (B)(6). ALTHOUGH SEVERAL ATTEMPTS MADE FOR EVENT DETAILS FROM PRODUCT RECEIVED THERE WAS NO RESPONSE FROM THE CUSTOMER OR ANY INDICATION OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8283706 ↗
• MalfunctionJan 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  PRODUCT RECEIVED UNEXPECTEDLY, THERE WAS A NOTE ATTACHED WITH THE RETURNED PRODUCT STATED; "DEFECTIVE, LEAKING WITH AN EVENT DATE (B)(6) 2018. ALTHOUGH SEVERAL ATTEMPTS MADE FOR EVENT DETAILS FROM PRODUCT RECEIVED THERE WAS NO RESPONSE FROM THE CUSTOMER OR ANY INDICATION OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281888 ↗
• MalfunctionJan 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER NOTICED A WET SPOT ON THE PATIENT'S BLANKET NEAR THE IV LINES DURING A CONTINUOUS INFUSION OF VERSED IN THE NICU. A SIMILAR LEAK WAS IDENTIFIED 2 DAYS PRIOR; BOTH TIMES THE LINES WERE CHANGED. THE USER APPLIED A GAUZE UNDER THE DISC TO DETERMINE THE LOCATION OF THE LEAK AND CONFIRMED THAT THE FLUID WAS COMING FROM THE FILTER. THE FACILITY WENT LIVE A COUPLE OF MONTHS AGO WITH THE FILTER SET, HOWEVER IN THE PAST 2 WEEKS THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET LEAKS AND COMPLAINTS. ALTHOUGH REQUESTED THE CUSTOMER DID NOT INDICATE ANY PATIENT HARM, NOR WERE FURTHER DETAILS OR INFORMATION GIVEN REGARDING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8244738 ↗
• MalfunctionJan 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A THAT THE USER NOTICED A WET SPOT ON THE PATIENTS BLANKET NEAR THE IV LINES DURING A CONTINUOUS INFUSION OF VERSED. IT WAS REPORTED THAT A WET SPOT WAS NOTED 2 DAYS PRIOR. THE USER APPLIED A GAUZE UNDER THE DISC TO DETERMINE THE LOCATION OF THE LEAK AND CONFIRM THAT THE FLUID WAS COMING FROM THE FILTER. AT BOTH TIMES THE IV LINES WERE CHANGED. THE FACILITY WENT LIVE A COUPLE OF MONTHS WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET COMPLAINTS. ALTHOUGH REQUESTED THE CUSTOMER DID NOT INDICATE ANY PATIENT HARM. THE EVENT OCCURRED IN THE NICU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8244506 ↗
• MalfunctionJan 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CONTINUOUS 24HR. INFUSION OF VERSED (1MG/1ML) AT A RATE OF 0.3ML/HR., THE TUBING WAS LEAKING AT THE CONNECTION OF THE IV SET AND THE ¿DISC¿ (PRESUMED TO MEAN THE FILTER) . THE IV WAS THE SET WAS ATTACHED TO THE BABY'S BROVIAC 4.2 FR. CATHETER, AT THE BABY¿S RIGHT CHEST WALL. THE FACILITY WENT LIVE A COUPLE OF MONTHS AGO WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET LEAKS. ALTHOUGH REQUESTED THE CUSTOMER DID NOT INDICATE ANY PATIENT HARM. THE EVENT OCCURRED IN NICU. ALTHOUGH REQUESTED, NO FURTHER INFORMATION OR DETAILS OF THE EVENT WERE GIVEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8242229 ↗
• MalfunctionNov 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED AT FILTER LEAK WHEN INFUSING TPN. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8078285 ↗
• MalfunctionNov 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A TUBING LEAK AT AN UNSPECIFIED LOCATION. IT WAS REPORTED THAT THE MALE ADAPTER WAS CHANGED AND THE SET WAS TIGHTENED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8078283 ↗
• MalfunctionNov 15, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED A LEAK FROM THE FILTER EXTENSION SET DURING A LIPID INFUSION IN THE NICU. THE LEAK APPEARED TO BE CAUSED BY A CLOGGED FILTER. ALTHOUGH REQUESTED THE CUSTOMER DID NOT INDICATE PATIENT HARM..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8076392 ↗
• MalfunctionNov 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A SYRINGE MODULE SET LEAKED AT THE CONNECTION TO THE FILTER DURING AN UNSPECIFIED NICU INFUSION. THE SET WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8076350 ↗
• MalfunctionNov 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SET WAS LEAKING CLEAR FLUIDS ONTO THE FLOOR. IT WAS REPORTED BY THE RN THAT THE PATIENT WAS IN THE RESTROOM AT THE TIME THE LEAK WAS NOTED , UNABLE TO IDENTIFY THE LOCATION OF THE LEAK OR WHICH SET PRIMARY OR SECONDARY WAS LEAKING .THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075010 ↗
• MalfunctionNov 14, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING AN UNSPECIFIED INFUSION, THE USER NOTED THAT THE PATIENTS BED WAS WET, UPON CLOSER EXAMINATION THE NURSE OBSERVED THAT THE FILTER WAS LEAKING. THERE WAS NO REPORT OF PATIENT HARM. THE EVENT OCCURRED IN THE (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8072351 ↗
• MalfunctionNov 6, 2018Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE TUBING SEPARATED AT THE FILTER WHEN INFUSING TPN. THE SET UP INCLUDED MEDICATION LINE ATTACHED TO TPN LINE ATTACHED TO PATIENT¿S SINGLE LUMEN PICC LINE. IT WAS REPORTED THAT THE USER NOTED BLOOD BACK FLOW ON PICC LINE. THE USER STATED THAT ALL CLAMPS WERE UNCLAMPED AND THERE WERE NO OCCLUSION ALARMS NOTED ON THE DEVICE. THE CHARGE NURSE WAS CALLED TO PATIENT BEDSIDE AND UPON FURTHER EXAMINATION FOUND THE MEDICATION LINE BROKE/SEPARATED AT THE FILTER. THERE WAS NO REPORT OF PATIENT HARM. THE EVENT OCCURRED IN THE (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8044955 ↗
• MalfunctionNov 6, 2018Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE TUBING SEPARATED AT THE FILTER WHEN INFUSING TPN. THE SET UP INCLUDED MEDICATION LINE ATTACHED TO TPN LINE ATTACHED TO PATIENT¿S SINGLE LUMEN PICC LINE. IT WAS REPORTED THAT THE USER NOTED BLOOD BACK FLOW ON PICC LINE. THE USER STATED THAT ALL CLAMPS WERE UNCLAMPED AND THERE WERE NO OCCLUSION ALARMS NOTED ON THE DEVICE. THE CHARGE NURSE WAS CALLED TO PATIENT BEDSIDE AND UPON FURTHER EXAMINATION FOUND THE MEDICATION LINE BROKE/SEPARATED AT THE FILTER. THERE WAS NO REPORT OF PATIENT HARM. THERE WAS NO REPORT OF PATIENT HARM. THE EVENT OCCURRED IN THE NICU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8044513 ↗
• MalfunctionNov 5, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AT 2246 THE MOTHER OF THE BABY REPORTED A LEAK ON THE BABY'S BLANKET. UPON EXAMINATION THE NURSE NOTED THAT THE FILTER PART OF THE MEDICATION LINE WAS LEAKING. AN UNSPECIFIED MEDICATION HAD BEEN GIVEN AT 2201, AND A FLUSH WAS INFUSING WHEN THE LEAK WAS NOTED. THE NURSE STOPPED THE INFUSION AND REMOVED THE FILTER, REATTACHED A NEW MEDICATION LINE, AND REORDERED NEW MEDICATION FROM THE PHARMACY. THERE WAS NO REPORT OF PATIENT HARM. THE SAMPLE RECEIVED WAS LABELED "TPN RUNNING."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039097 ↗
• MalfunctionOct 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED DURING A FENTANYL AND DOPAMINE INFUSION, A LEAK WAS NOTED BELOW BOTH 0.2 MICRON FILTERS ON THE EXTENSION SETS. IT WAS REPORTED BY THE CLINICIAN THAT BOTH SETS WERE NEW WHEN THE LEAK OCCURRED. THERE WAS NO REPORT OF PATIENT HARM. THE EVENT OCCURRED N PICU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001965 ↗
• MalfunctionOct 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED DURING A FENTANYL AND DOPAMINE INFUSION, A LEAK WAS NOTED BELOW BOTH 0.2 MICRON FILTERS ON THE EXTENSION SETS. IT WAS REPORTED BY THE CLINICIAN THAT BOTH SETS WERE NEW WHEN THE LEAK OCCURRED. THERE WAS NO REPORT OF PATIENT HARM. THE EVENT OCCURRED IN PICU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001554 ↗