Alaris 10839681Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885403234538), received between Nov 13, 2020 and Mar 17, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Crack; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED BY CUSTOMER THAT ONE OF THE PORTS IN A TRIFUSE IV TUBING HAD A HOLE IN IT. THIS WAS NOTICED DURING PATIENT USE, THE PATIENT¿S BLOOD WAS FOUND BACKING UP THROUGH ONE OF THE PORTS AND LEAKING ONTO HER SKIN. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618187 ↗
• MalfunctionSep 16, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: SETS LEAKING AT CONNECTIONS AFTER 3 HOURS INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233620 ↗
• MalfunctionSep 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET LEAKED AT THE LUMEN OF A PORT THAT WAS NOT IN USE RESULTING IN HYPOTENSION AND NEED FOR FLUID RESUSCITATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR ADULT MICU EXPERIENCED ISSUES WITH BD SMALLBORE EXTENSION SET. THE FEEDBACK BELOW CAME FROM NURSING STAFF: PATIENT RECEIVED ON SAME DOSE OF LEVO AND VASO RUNNING THROUGH TRIFLO LUMEN. DOSES WERE NOT CHANGED, BUT MIDSHIFT, PATIENT'S BP WAS 70S/40S, PRIMARY RN GOING UP ON LEVO AND VASO, BUT PATIENT BP WAS NOT RESPONDING. PRIMARY RN NOTICED THAT PATIENT'S GOWN WAS WET AND NOTICED THAT THE MEDICATION WAS LEAKING THROUGH ONE OF THE LUMENS ON THE TRIFLO THAT WAS NOT CONNECTED TO A MEDICATION. OF NOTE, THAT LUMEN WAS NOT CLAMPED. PRIMARY RN CLAMPED LUMEN, RESUSCITATED WITH NS BOLUS (AS PER ORDER) AND WAS ABLE TO COME DOWN ON THE PRESSOR DOSES TO BASELINE.

  Patient problems: Insufficient Information

  MAUDE report 17702699 ↗
• MalfunctionSep 5, 2023Backflow; Defective Component; Backflow; Defective Component

  IT WAS REPORTED WHILE USING BD SMALLBORE TRIFUSE EXTENSION SET BLOOD BACKFLOWED DURING INFUSION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR ADULT MICU EXPERIENCED ISSUES WITH BD SMALLBORE EXTENSION SET, REF: (B)(4) . THE FEEDBACK BELOW CAME FROM NURSING STAFF: PATIENT RECEIVED ON SAME DOSE OF LEVO AND VASO RUNNING THROUGH TRIFLO LUMEN. DOSES WERE NOT CHANGED, BUT MIDSHIFT, PATIENT'S BP WAS 70S/40S, PRIMARY RN GOING UP ON LEVO AND VASO, BUT PATIENT BP WAS NOT RESPONDING. PRIMARY RN NOTICED THAT PATIENT'S GOWN WAS WET AND NOTICED THAT THE MEDICATION WAS LEAKING THROUGH ONE OF THE LUMENS ON THE TRIFLO THAT WAS NOT CONNECTED TO A MEDICATION. OF NOTE, THAT LUMEN WAS NOT CLAMPED. PRIMARY RN CLAMPED LUMEN, RESUSCITATED WITH NS BOLUS (AS PER ORDER) AND WAS ABLE TO COME DOWN ON THE PRESSOR DOSES TO BASELINE. PREVIOUSLY WE WERE USING DIFFERENT TRIFLOWS THAT SEEMED TO HAVE WORKED FINE (ICU MEDICAL MX458L), BUT I HAVE HEARD FROM SEVERAL RNS THAT REPORTED MEDICATION AND EVEN BLOOD WOULD BACK UP INTO THIS TRIFLO (BD 10839681). THIS WOULD HAPPEN WHEN NO MEDICATION WAS RUNNING AND DURING A KVO INFUSION THAT WAS RUNNING AT 3ML/HOUR. IN

  Patient problems: Insufficient Information

  MAUDE report 17687636 ↗
• MalfunctionJun 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (EXTENSION SET LEAKING REFER PR (B)(4)). EVENT 1: LEAKING FROM TRI PORT EXT SET W/LL DEHP FREE, LOT NUMBER: 21109122. EVENT 2: LEAKING FROM TRI PORT EXT SET W/LL DEHP FREE, LOT NUMBER: 21099260.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121122 ↗
• MalfunctionJun 5, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING FROM EXTENSION SET WHERE ON THE EXTENSION SET WAS THE LEAKAGE? THE STAFF ISN¿T AWARE OF EXACTLY WHERE IT WAS LEAKING FROM. DID THIS HAPPEN WITH MULTIPLES UNITS FROM A LOT? THE STAFF DIDN¿T KEEP THE LOT #. DID THIS HAPPEN WITH MULTIPLE PLACERS/CLINICIANS? THIS HAS NOW HAPPENED MULTIPLE TIMES ON TWO DIFFERENT UNITS. WAS THERE ANY HARM TO PATIENT(S)? WE ARE NOT AWARE OF ANY PERMANENT HARM, BUT THE PATIENT HAD AT A MINIMUM, TEMPORARY DISCOMFORT. ADDITIONAL MEDICATIONS WERE NEEDED DUE TO THE LEAKAGE.

  Patient problems: Discomfort

  MAUDE report 17056631 ↗
• MalfunctionDec 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD EXTENSION SET SMALLBORE TRIFUSE 4 SLIDE CLAMP LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD A FEW REPORTS OF 10839681 LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928447 ↗
• MalfunctionJul 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRI-PORT EXT SET W/LL DEHP FREE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECEIVED NOTICE FROM OUT CLINICIANS THAT THE FOLLOWING PRODUCT WAS LEAKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112014 ↗
• MalfunctionNov 13, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRI-PORT EXT SET W/LL DEHP FREE EXPERIENCED DEVICE DAMAGE/DEFORMATION AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10839681 BATCH NO.: UNKNOWN. TRIFURCATE ATTACHED TO PATIENT CRACKED AND LEAKING, ISSUE DISCOVERED WHEN RN FLUSHED PORT PRIOR TO STARTING PLATELET INFUSION. CRACK NOTED ON YELLOW PORTION OF EXTENSION SET (PIECE THAT CONNECTS TO THE MICROCLAVE/CAP, CONFIRMED LEAKING AT THIS POINT BY DISCONNECTING TRIFURCATE FROM PATIENT AND FLUSHING IT AGAIN).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10840219 ↗