Alaris, SmartSite 20062ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613203011853), received between Jul 15, 2019 and Jul 31, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Backflow” (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. Oct 11, 2023Class IIOpen, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0351-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Backflow; Backflow

  IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD SMARTSITE¿ EXTENSION SET THERE WAS BACKFLOW OF MEDICATION WHEN CLAMPED. 1 OF 2 REPORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED ISSUES HAVE TO DO WITH THE BACKFLOW OF MEDICATIONS EVEN IF THE PORTS ARE CLAMPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17426055 ↗
• MalfunctionJul 31, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD SMARTSITE¿ EXTENSION SET THE CONNECTIONS WERE DIFFICULT TO DISCONNECT. 2 OF 2 REPORTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED ISSUES WITH THE CLAVE CONNECTIONS SUCH AS TROUBLE REMOVING THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17425761 ↗
• MalfunctionNov 19, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE BLUE CONNECTION PORT ON THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET WAS FOUND DEPRESSED UPON OPENING THE PACKAGE, AND REMAINED SO AFTER FLUSHING THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE FREE VALVE OF TRIFUSE PACKAGED WAS MALFUNCTIONED UPON OPENING. BLUE CONNECTION PORT THAT IS USUALLY DEPRESSED (OPENING THE SYSTEM) WHEN CONNECTED TO NEEDLELESS CONNECTORS WAS DEPRESSED UPON OPENING PACKAGE. LINE WAS FLUSHED AND THE PORT STILL REMAINED DEPRESSED. THESE CONNECTIONS DO NOT REQUIRE A CAP AND WOULD LEAVE LINE PORT ACCESSED WHILE CONNECTED TO PATIENT. ADDITIONAL INFORMATION RECEIVED 01-NOV-2022 WAS THE PRODUCT USED? IT WAS ONLY PRIMED, NOT USED ON PATIENT. IT WAS MENTIONED THAT THERE WAS POTENTIAL HARM. WAS THERE ANY ACTUAL PATIENT HARM/IMPACT? NO .IS THE PRODUCT CONTAMINATED WITH CHEMO? NO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15830475 ↗
• MalfunctionNov 26, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE TRI-PORT EXT CHK VLV W/3 VP, 7 DAY CENTRAL LINE WAS BLOCKED BIDIRECTIONALLY DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CENTRAL LINE WITH FILTER OR ONE WAY VALVE IS BLOCKED BIDIRECTIONALLY, AND THEREFORE USELESS."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10909919 ↗
• MalfunctionJul 15, 2019False Alarm; Improper Flow or Infusion; Insufficient Device Problem Information; False Alarm; Improper Flow or Infusion; Insufficient Device Problem Information

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT WHICH STATES, "BOLUS IV FLUIDS ORDERED FOR PT,NEW TUBING OBTAINED AND TRIED 3 SEPARATE CHANNELS BUT KEPT ALARMING SAYING "AIR-IN-LINE". CHANGED TUBING AND PROBLEM WAS RESOLVED. FDA SAFETY REPORT 10# ''(8)(4)''." IT WAS REPORTED THAT PATIENT WAS RECEIVING A PRIMARY INFUSION OF A NORMAL SALINE BOLUS WHEN THE DEVICE CONTINUED TO ALARM FOR AIR IN LINE. THE USER TRIED 3 DIFFERENT DEVICES THEN CHANGED OUT THE TUBING WITHOUT FURTHER ISSUES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791687 ↗