Alaris 10010483Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10885403232602), received between Apr 24, 2018 and Jun 17, 2025 — classified as 1 injury, 58 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

3 FDA recall records name this device's identifier, 3 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. Jul 8, 2025Open, Classified

   Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

   Z-2180-2025 · Root cause: Under Investigation by firm · FDA record ↗

3. 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE 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 TEXIUM LEAK - BONDED TEXIUM CLOSED MALE LUER.

  Patient problems: Chemical Exposure

  MAUDE report 22216811 ↗
• MalfunctionMay 19, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT "WHILE THE SYRINGE IS INFUSING YOU CAN PUSH THE PLUNGER DOWN AND IT WILL BOLUS THE MEDICATION INTO THE PATIENT DESPITE THE RATE BEING SET ON THE PUMP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049269 ↗
• MalfunctionApr 17, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SYRINGE ADAPTER SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. I HAVE A PICTURE ATTACHED OF THE PRODUCT INFORMATION HERE BUT OUR UNIT IS SEEING A HUGE AMOUNT OF ISSUES WITH THE SYRINGE TUBING ACCUMULATING AIR IN THE LINE. OUR NURSES SEEM TO THINK SOMETHING MAY BE WRONG WITH THE VENTS AND NOT ALLOWING AIR IN THE SYRINGE AND THEREFORE IT BUILDS UP IN THE TUBING. WE HAVE PLACED A MEDWATCH ON THIS PRODUCT BUT I WANTED TO REACH OUT DIRECTLY TO SEE IF YOU ARE SEEING THIS ISSUE IN PARTICULAR AND IF THERE ARE ANY OTHER PRODUCT OPTIONS OR TROUBLESHOOTING WE CAN DO! WE SO APPRECIATE YOU ALL!

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862456 ↗
• MalfunctionDec 29, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SYRINGE ADAPTER SET WAS BREAKING OFF THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE HUB OF THE SYRINGE IS VERY PLIABLE SO IF THE SYRINGE IS ACCIDENTLY HIT WHILE ON PUMP, IT CAN COME OFF TUBING OR BREAK OFF.

  Patient problems: Insufficient Information

  MAUDE report 21032674 ↗
• MalfunctionFeb 26, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SYRINGE ADAPTER SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THIS COMPLAINT CREATED FOR DISPOSABLES. WHEN USING SET NUMBER (B)(4) THEY HAVE ABOUT 6MLS OF DRUG GLOFITAMAB LEFT IN THE SYRINGE. STATES THIS DOES NOT HAPPEN WITH IVIG WHEN USING THE SAME SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18779295 ↗
• MalfunctionFeb 26, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SYRINGE ADAPTER SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THE ISSUE IS NOT THAT THE FLUIDS ARE LEFT OVER, IT IS THAT IT STARTS ALARMING AIR IN LINE ALMOST NON-STOP, WHEN THERE IS NO AIR, ONCE IT GETS DOWN TO 3-4 MLS. WHEN IT IS ONLY INFUSING AT 6.25 MLS/HR, IT REQUIRES CONSTANT ATTENTION TO COMPLETE THE INFUSION. WHEN HITTING RESTART ON THE PUMP, IT EVENTUALLY INFUSES ALL OF THE DRUG ALLOWING FOR THE FLUSH TO FOLLOW BUT IT IS A PAINFUL HALF HOUR OR SO THAT BASICALLY ENDS UP REQUIRING 1:1 CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775316 ↗
• MalfunctionNov 6, 2023Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: 10010483, BATCH #: 22125363. IT WAS REPORTED BY CUSTOMER THAT LEAKING AND WILL NOT STAY CONNECTED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REPORTED ISSUE: LEAKING AND WILL NOT STAY CONNECTED. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. ITEM: 10010483. QUANTITY AFFECTED: 38 CASES. SERIAL/LOT NUMBER: (B)(6). PO : 4516628311. INJURIES OR ADVERSE EVENT: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081297 ↗
• MalfunctionSep 5, 2023Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SYRINGE ADAPTER SET HAD DISCOLORATION OF DEVICE. REPORT 3 OF 3. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: DISCOLORATION IN THE ¿PUMPING SEGMENT¿ OF THE ALARIS SYRINGE ADAPTOR SET AFTER LOSEC INFUSION. PURPLE DISCOLORATION OF THE PUMPING SEGMENT NOTICES AFTER INFUSION OF LOSEC. NOTICED WITH THREE PATIENTS WHO RECEIVED LOSEC INFUSION DURING THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686789 ↗
• MalfunctionSep 5, 2023Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SYRINGE ADAPTER SET HAD DISCOLORATION. REPORT 1 OF 3. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: DISCOLORATION IN THE ¿PUMPING SEGMENT¿ OF THE ALARIS SYRINGE ADAPTOR SET AFTER LOSEC INFUSION. PURPLE DISCOLORATION OF THE PUMPING SEGMENT NOTICES AFTER INFUSION OF LOSEC. NOTICED WITH THREE PATIENTS WHO RECEIVED LOSEC INFUSION DURING THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686314 ↗
• MalfunctionSep 5, 2023Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SYRINGE ADAPTER SET HAD DISCOLORATION OF DEVICE. REPORT 2 OF 3. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: DISCOLORATION IN THE ¿PUMPING SEGMENT¿ OF THE ALARIS SYRINGE ADAPTOR SET AFTER LOSEC INFUSION. PURPLE DISCOLORATION OF THE PUMPING SEGMENT NOTICES AFTER INFUSION OF LOSEC. NOTICED WITH THREE PATIENTS WHO RECEIVED LOSEC INFUSION DURING THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686098 ↗
• MalfunctionDec 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SYRINGE ADAPTER SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV SET TUBING LIPID PLUG IS LEAKING. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947878 ↗
• MalfunctionDec 5, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SYRINGE ADAPTER SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A SMALL METAL TUBE WHERE THE SYRINGE CONNECTS TO THE TUBING. THIS SMALL TUBE DOESN'T ALLOW THE SYRINGE TO FULLY PLUNGE AND ADMINISTER ALL OF THE MEDICATION IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921140 ↗
• MalfunctionDec 29, 2021Defective Component; Defective Device; Defective Component; Defective Device

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SYRINGE ADAPTER SET TUBING WAS DEFECTIVE AND COULDN'T CONNECT TO THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE A DEFECTIVE LOT OF TUBING." "PULLING FROM BOTH PARTS. THE THREADING ON THE VERY TOP OF THE SET WHERE THE SYRINGE TWISTS ON IS MADE INCORRECTLY SO THEY SYRINGE DOESN¿T LOCK IN, IT JUST SPINS AND FALLS OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114360 ↗
• MalfunctionMay 27, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE AS LVP VSA SMBORE TUBING LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR NURSES TURNED IN A DIFFERENT TUBING SET THAT IS LEAKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898836 ↗
• MalfunctionFeb 18, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE AS LVP VSA SMBORE TUBING LUER LOCK CONNECTION SEPARATED FROM THE PUMP. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALARIS SYRINGE PUMP TUBING WITH DISCONNECTION OF LUER LOCK CONNECTION PIECE AT THE DISTAL END OF TUBING. IV MEDICATION INFUSION DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11346080 ↗
• MalfunctionSep 29, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT 4 GEMINI SYRINGE VTD SET, DEHP FREE EXPERIENCED AIR BUBBLES/AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE ARE THE USED PRODUCTS SUBMITTED TO ME BY XXXXXXXX THAT ALSO HAD AIR IN LINE ISSUES. X3 SYRINGE SET REF # (B)(4): 1 LOW SORB TUBING WITH 0.2 MICRON FILTER REF # (B)(4): 1 SYRINGE SET (INFUSING IL) REF # (B)(4): 1 BLUE FILTER WITH 1.2 MICRON FILTER ATTACHED TO THE PRIOR SYRINGE. 1 SMARTSITE TRIPLE CONNECTOR REF # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10603115 ↗
• MalfunctionSep 22, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP 20D DEHP 2SS CV TUBING LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10010483 BATCH NO: 19116172 IT WAS REPORTED LEAKAGE DURING PRIMING WHERE VENT MEETS THE MAIN LINE. CUSTOMER EMAIL (B)(6) 2020: ¿ BOTH INCIDENTS HAPPENED ON (B)(6) 2020. ¿ SAME DEFECT FOR BOTH INSTANCES, CAN BE PUT UNDER 1 PRODUCT COMPLAINT. ¿ NO PATIENT HARM. ¿ PLEASE RETURN BOTH SETS OF TUBING. ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿. CUSTOMER EMAIL (B)(6) 2020: NICU BROUGHT THREE PRODUCT SAFETY ISSUES TO OUR ATTENTION INVOLVING IV TUBING. IN ALL INCIDENTS A PATIENT WAS CONNECTED TO THE TUBING DURING MALFUNCTION. 1. REF#(B)(4) - LOT#(10)20063048- WHEN PRIMING NEW TPN TUBING, THE TUBING BECAME DISCONNECTED/ BROKE AT THE DISTAL Y-SITE. 2. REF#(B)(4) - NO LOT NUMBER AVAILABLE- TUBING LEAKING DURING PRIMING WHERE VENT MEETS THE MAIN LINE. 3. REF#(B)(4) - LOT# (10)19116172- TUBING LEAKING DURING PRIMING WHERE VENT MEETS THE MAIN LINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10570920 ↗
• MalfunctionJun 16, 2020Break; Break

  THE CUSTOMER RECEIVED THE IV TUBING SETS FROM STAFF WITH NO INFORMATION, AND REPORTED THAT THERE WAS AN UNSPECIFIED IV TUBING SET ISSUE. WHEN THE PRODUCTS WERE RECEIVED, IT WAS NOTED THAT THE TUBING SETS HAD BROKEN AT THE UPPER FITMENT CONNECTION TO THE SYRINGE ADAPTER. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO A PATIENT FROM ANY EVENT INVOLVING THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10159225 ↗
• MalfunctionJun 16, 2020Break; Break

  THE CUSTOMER RECEIVED THE IV TUBING SETS FROM STAFF WITH NO INFORMATION, AND REPORTED THAT THERE WAS AN UNSPECIFIED IV TUBING SET ISSUE. WHEN THE PRODUCTS WERE RECEIVED, IT WAS NOTED THAT THE TUBING SETS HAD BROKEN AT THE UPPER FITMENT CONNECTION TO THE SYRINGE ADAPTER. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO A PATIENT FROM ANY EVENT INVOLVING THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10159212 ↗
• MalfunctionJun 16, 2020Break; Break

  THE CUSTOMER RECEIVED THE IV TUBING SET FROM STAFF WITH NO INFORMATION, AND REPORTED THAT THERE WAS AN UNSPECIFIED IV TUBING SET ISSUE. WHEN THE PRODUCT WAS RECEIVED, IT WAS NOTED THAT THE TUBING SET HAD BROKEN AT THE UPPER FITMENT CONNECTION TO THE SYRINGE ADAPTER. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO A PATIENT FROM ANY EVENT INVOLVING THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10159153 ↗
• MalfunctionJun 15, 2020Break; Break

  IT WAS REPORTED THAT THE SYRINGE ADAPTOR SMALL BORE IV TUBING SET INFUSING PRECEDEX "SNAPPED" DURING TRANSPORT WHEN A CLINICIAN'S ELBOW HIT THE DEVICE WHILE TRANSFERRING THE PUMP FROM THE CRIB TO THE OPERATING ROOM IV POLE. THE PATIENT WAS ALREADY UNDER INHALATIONAL ANESTHESIA AND THEREFORE THERE WAS NO LAPSE IN SEDATION OR ANY ADVERSE EFFECT ON THE PATIENT DUE TO THE EVENT. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10153496 ↗
• MalfunctionJun 14, 2020Break; Break

  IT WAS REPORTED THAT THE IV TUBING SET "SNAPPED" AT THE CONNECTION OF THE SYRINGE ADAPTER "WHITE PIECE" AND THE UPPER FITMENT OF THE TUBING, CAUSING AN INTERRUPTION OF AN EPINEPHRINE INFUSION TO THE IMMEDIATE POSTOPERATIVE PATIENT. THE CLINICIAN CLAMPED THE LINE AND RESTARTED THE INFUSION USING A NEW TUBING SET. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10151532 ↗
• MalfunctionMay 29, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SYRINGE SET CRACKED AT THE BLUE CONNECTION.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 10100948 ↗
• MalfunctionApr 27, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SYRINGE ADAPTER SET BROKE AT THE TOP. IT WAS NOTED THAT NO MEDICATION WAS INFUSING AT THE TIME OF THE EVENT. THE EVENT OCCURRED IN PEDIATRICS UNIT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Information

  MAUDE report 10003725 ↗
• MalfunctionMar 26, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT UPON OPENING THE PUMP DOOR TO REMOVE THE SET, THE SYRINGE ADAPTER TUBING SEPARATED AT THE SAFETY CLAMP. IT WAS NOTED THAT NORMAL SALINE WAS INFUSING AT THE TIME OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Information

  MAUDE report 9884967 ↗