Alaris, SmartSite 10012645Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403233753), received between Sep 27, 2022 and Nov 21, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

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. Sep 11, 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-0035-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MATERIAL#: 10012645 BATCH#: UNKNOWN ( PROVIDED# 1023095681 ). IT WAS REPORTED BY THE CUSTOMER THAT WHEN FLUSHING BAG 3 OF 3 OF THE AUTOLOGOUS TRANSPLANT THE LINE FROM THE CELL BAG TO THE CHAMBER DID NOT PULL THE CELLS TO THE CHAMBER ONE THE BAG ITSELF WAS EMPTY. THIS RN AND BROOKE HENNING, RN MADE SURE THE THERE WERE NO KINKS OR OBSTRUCTIONS. FILLED THE CHAMBER FROM THE SALINE BAG AND PROCEEDED TO FINISH RUNNING THE REMAINING CELLS LEFT IN THE LINE. THE SAME THING OCCURRED A SECOND TIME. WE THEN FILLED THE CHAMBER WITH SALINE AGAIN AND HELD THE SALINE BAG LOWER THAN THE CELL BAG, KINKED THE SALINE TUBING SO IT WOULD NOT PULL FROM THE SALINE LINE. THE CELLS WERE THEN ABLE TO CLEAR THE LINE FROM THE BAG TO THE CHAMBER SO THAT THE PATIENT COULD GET ALL OF HER CELLS. THE TUBING LOT NUMBER IS 1023095681 EXP. 09/12/2026. CELL BAG 3 OF 4 PRODUCT # 24LA301 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN FLUSHING BAG 3 OF 3 OF THE AUTOLOGOUS TRANSPLANT THE LINE FROM THE CELL BAG TO THE CHAMBER DID NOT PULL THE CELLS TO THE CHAMBER ONE THE BAG ITSELF WAS EMPTY. THIS RN AND BROOKE HENNING, RN MADE SURE THE THERE WERE NO KINKS OR OBSTRUCTIONS. FILLED THE CHAMBER FROM THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751590 ↗
• MalfunctionJan 23, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET TUBING WAS DEFECTIVE DETACHED FROM THE DRIP CHAMBER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DID YOU KEEP THE DEFECTIVE TUBING? NO, TUBING WAS CONTAMINATED WITH BLOOD THAT COULD NOT BE CONTAINED DUE TO NATURE OF TUBING FAILURE." "THE ¿LID¿ PORTION OF THE DRIP CHAMBER DETACHED FROM THE ACTUAL CHAMBER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16230061 ↗
• MalfunctionJan 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DRIP CHAMBER SEPARATED FROM THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DRIP CHAMBER CAME APART AT THE CONNECTION OF THE LID AND BOWL"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218972 ↗
• MalfunctionSep 27, 2022Defective Component; Defective Component

  IT WAS REPORTED WHILE USING A BD ALARIS¿ LVP 20D DEHP SS CV THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING THAT WAS NOTED TO BE DAMAGED/BROKEN UPON OPENING. IT DID NOT IMPACT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491747 ↗