Alaris 10241342Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403234170), received between Nov 3, 2021 and Nov 27, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Leak/Splash; Leak/Splash

  MATERIAL # 10241342. BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE CONNECTION BETWEEN TWO PRODUCTS LEAKED WHILE THE PUMP WAS ACTIVE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE USE BD EXTENSION SET SMALLBORE TUBING 1.2 M LOW PROTEIN BINDING FILTER (REF 20129E) IN CONJUNCTION WITH BD EXTENSION SET AMBER TUBING (REF 10241342) FOR DELIVERY OF LIPID SOLUTIONS IN OUR NEONATAL INTENSIVE CARE UNIT. WE HAVE EXPERIENCED MULTIPLE (>5) INCIDENTS OVER THE PAST YEAR IN WHICH THE CONNECTION BETWEEN THESE TWO PRODUCTS LEAKED WHILE THE PUMP WAS ACTIVE. INITIALLY, THE SUSPECTED ISSUE WAS POSSIBLY OVERTIGHTENING BY EITHER PHARMACY COMPOUNDER OR NURSE. HOWEVER, THE REPEATED NATURE OF THESE EVENTS - EVEN AFTER ALERTING STAFF TO ENSURE ONLY TIGHTENING THE CONNECTION UNTIL IT STOPS - HAS GIVEN CAUSE TO THINK THIS MAY BE A PRODUCT ISSUE. WE ARE CONCERNED THAT THIS MAY AFFECT THE DELIVERED VOLUME AS WELL AS THE STERILITY OF THE SYSTEM IF THE CONNECTION IS NOT MAKING AN ADEQUATE SEAL. IS THIS A CONCERN THAT HAS ARISEN ELSEWHERE? ARE THERE ANY SUGGESTED TECHNIQUES ASIDE FROM EXISTING PRODUCT LITERATURE? ARE THESE TWO PRODUCTS COMPATIBLE? ARE THERE BETTER SOLUTIONS FOR ADMINISTRATION OF LIPIDS W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798568 ↗
• MalfunctionJul 25, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE AMBER TUBING DOES NOT CONSISTENTLY SEAT PROPERLY WITH THE LIPID FILTERS (BD (B)(4)). THIS HAS BEEN FOUND ON 4 PATIENTS. THE ENDS OF THE LIPID FILTERS SEEM TO HAVE A DIFFERENT COLOR PLASTIC AND MAKE A FRICTION NOISE WHEN CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828536 ↗
• MalfunctionNov 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED BD ALARIS EXTENSION SET HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONNECTION WHERE THE ALANS IV TUBING EXTENSION SET CONNECTS TO THE LIPID FILTER LEAKED SLOWLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745232 ↗