Alaris, SmartSite 10015896Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403234064), received between Jun 23, 2021 and Sep 24, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 reports).

1 FDA recall record name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 8, 2025Class IOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS MISSING COMPONENT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT WE ARE HAVING A DIFFICULT TIME PRODUCT DAMAGE- TUBING WAS LEAKING, MISSING ROLLER CLAMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297392 ↗
• MalfunctionSep 24, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT WE ARE HAVING A DIFFICULT TIME WITH PRODUCT DAMAGE- TUBING WAS LEAKING, MISSING ROLLER CLAMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297391 ↗
• MalfunctionOct 31, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: CUSTOMER STATS I ALSO WANTED TO PASS ALONG THAT WE ENTERED APPROXIMATELY 4-5 MIDAS FOR THE REF# 10015896, AFTER CONNECTING THE TUBING WE FOUND MULTIPLE LEAKS THROUGHOUT THE TUBING HUB AREAS. NOT SURE IF YOU HEARD THIS FROM ANYONE ELSE? SHOULD THE FOLLOW UP COMMUNICATION BE SENT TO YOU? YES PLEASE. WERE ANY OF THE SETS SAVED TO SEND IN FOR EVALUATION? NOT AT THIS TIME, IF WE HAVE ANOTHER ISSUE, I WILL MAKE SURE TO PASS ALONG TO THE TEAM TO SAVE THE TUBING. IN MEANTIME, WE HAVE INSTRUCTED THE TEAM TO TIGHTEN EACH HUB AREA BEFORE DELIVERING MEDICATION/FLUIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041481 ↗
• MalfunctionApr 13, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE SMARTSITE INFUSION SET THE TUBING SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV TUBING BROKE AT A CONNECTION WHERE THE TUBING SHOULD BE SEALED. THE TUBING WAS NOT PULLED OR YANKED, IT JUST FELL APART. ONCE THE DISCONNECTION WAS NOTED, THE ENTIRE IV TUBING WAS REMOVED AND BAGGED. THERE WAS NO AIR IN THE SHORT PIGTAIL AND THE IV WAS EASILY FLUSHED AND HAD GOOD BLOOD RETURN. NEW TUBING WAS CONNECTED AND THE IV INFUSION WAS RESUMED. NO NEED TO REMOVE OR RESTART THE IV. EVENT DID NOT CAUSE ANY DELAY IN TREATMENT OR PREVENT A TIMELY DISCHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740562 ↗
• MalfunctionNov 18, 2022Defective Device; Defective Device

  IT WAS REPORTED WHILE USING BD AS LVP 10D 3SS 2G-4WSPK CV THE CONNECTION WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONNECTION SITE WAS MISSHAPED, WOULD NOT PROPERLY FIT INTO IV SITE PROPERLY. IV TUBING CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824024 ↗
• MalfunctionJan 26, 2022Break; Break

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT BREAKING AT MULTIPLE JUNCTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13360862 ↗
• MalfunctionJan 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV TUBING KEEPS DISCONNECTING FROM THE 2 GANGED 4-WAY STOPCOCKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13335543 ↗
• MalfunctionJun 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE GEM 10DP CKV 3SS 2G 4WAY STCK EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:10015896. BATCH/ LOT #: UNKNOWN. WHEN ARRIVING TO MED SURGE 3. THE MED SURG RN NOTICED THAT THE IV TUBING WAS WET. THE TUBING WAS REMOVED FROM THE PATIENT AND THE LINE WAS CAPPED. THE TUBING WAS LEAKING FROM THE BLUE PIECE THAT PLUGS INTO THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051908 ↗