Alaris 10942011Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 277cm (109 in) · Class 2
Quick summary
This BD Alaris pump infusion set, an IV tubing set used with infusion pumps, has 106 reports, no deaths and 1 injury. Many reports describe leaks, tubing breaking or separating at connections, and air getting into the line, and a few describe free flow or backflow of fluid. Some reports note that medication spilled when tubing broke. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 106
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10885403232404), received between Dec 7, 2018 and Jun 19, 2026 — classified as 1 injury, 99 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (36 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash36
- Break13
- Free or Unrestricted Flow12
- Air/Gas in Device11
- Material Separation8
- Backflow7
- Complete Blockage5
- Defective Component5
Patient problems
- No Clinical Signs, Symptoms or Conditions74
- No Consequences Or Impact To Patient22
- Insufficient Information9
- No Information2
- Low White Blood Cell Count1
Recent adverse event reports
The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2026Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. IT WAS REPORTED BY A CUSTOMER THAT THE IV TUBING'S UNBONDED CONNECTION BROKEN AT HUB OF TIP WHICH IS INSERTED INTO IV PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565005 ↗MalfunctionJun 19, 2026Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE IV TUBING'S UNBONDED CONNECTION BROKEN AT HUB OF TIP WHICH IS INSERTED INTO IV PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564920 ↗MalfunctionJun 19, 2026Break; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET BROKE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT TUBING BROKE ON PATIENT IT WAS LEAKING, EMPTIED A BAG OF FENTANYL ON THE FLOOR. SET HAD NO Y SITES HAS TUBING AND BAG. LEAKING AT "TUBING HOLDER" NEAR THE TOP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564521 ↗MalfunctionJun 19, 2026Break; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS BROKE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT TUBING BROKE ON PATIENT IT WAS LEAKING, EMPTIED A BAG OF FENTANYL ON THE FLOOR. SET HAD NO Y SITES HAS TUBING AND BAG. LEAKING AT "TUBING HOLDER" NEAR THE TOP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564219 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT THE BD ALARIS PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING BROKE ON PATIENT IT WAS LEAKING, EMPTIED A BAG OF FENTANYL ON THE FLOOR. NO PATIENT HARM OCCURRED- THE DRUG RAN ONTO THE FLOOR INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344336 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT THE BD ALARIS PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING BROKE ON PATIENT IT WAS LEAKING, EMPTIED A BAG OF FENTANYL ON THE FLOOR. NO PATIENT HARM OCCURRED- THE DRUG RAN ONTO THE FLOOR INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344322 ↗MalfunctionMay 31, 2026Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT "THE AIR VENT ON THE IV TUBING WAS LEAKING MTX OUT OF IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25341044 ↗MalfunctionApr 30, 2026Infusion or Flow Problem; Air/Gas in Device
IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT IV TUBING WAS PRIMED AND CONNECTED TO PATIENT, THE NEXT SHIFT NOTICED THE TUBING WAS FULL OF AIR. DISCONNECTED FROM PATIENT AND ATTEMPTED TO RE-PRIME PURGE TUBING WITH NO SUCCESS. LINE REMOVED AND REPLACED WITH NEW SET-UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048624 ↗MalfunctionApr 15, 2026Contamination; Contamination /Decontamination Problem
IT WAS REPORTED, BROWN PARTICLE FOUND IMBEDDED INTO PLASTIC OR ON INSIDE OF PLASTIC DRIP CHAMBER OF IV PUMP INFUSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886527 ↗MalfunctionApr 10, 2026Separation Failure
IT WAS REPORTED BY CUSTOMER THAT IV TUBING DISCONNECTED NEAR THE FLUID CHAMBER, RESULTING IN MEDICATION SPILLING ONTO THE FLOOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839406 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED RN DISCONNECTED IV TUBING FROM NEEDLESS ACCESS DEVICE - NAD; PART OF IV TUBING BROKE AND REMAINED IN NAD.
Patient problems: Insufficient Information
MAUDE report 24675146 ↗MalfunctionFeb 13, 2026Leak/Splash
PATIENT HAS A PICC AND NEEDED A CAP CHANGE IN IV TUBING CHANGED. LINES WERE PRIMED AND ONE OF THE IV TUBING STARTED TO LEAK SOFT PART THAT GOES INTO THE ALARIS PUMP. THE IV TUBING WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 24335561 ↗MalfunctionFeb 12, 2026Separation Failure; Activation, Positioning or Separation Problem
ADDITIONAL INFORMATION FROM CUSTOMER: THE CONNECTION OCCURRED INSIDE THE HOOD BEFORE PRIMING OCCURRED. THE TUBE WAS DRY AND NOTHING LEAKED INSIDE THE HOOD. THERE WAS NO REPORTED ADVERSE EVENT OR INJURY ASSOCIATED WITH THIS EVENT. I DO NOT THINK THE DETACHED LINE HAD ANYTHING TO DO WITH A SPECIFIC PHASEAL BECAUSE WE REPLICATED THE CONNECTION OUTSIDE OF THE CLEANROOM WITH A DIFFERENT PHASEAL. THE LINE ALSO DETACHED FROM THE SPINNING PIECE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326887 ↗MalfunctionJan 13, 2026Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT WAS ACTIVELY RUNNING METHOTREXATE THROUGH PROPERLY PREPARED TUBING. THE PATIENT'S PARENTS CALLED OUT AND INFORMED STAFF THAT CHEMO WAS LEAKING FROM THE TUBING. IT WAS QUITE CLEAR THAT IT WAS THE CHEMO LEAKING BECAUSE THE LIQUID COMING FROM THE LINE WAS YELLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052267 ↗MalfunctionDec 16, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE LEAKING WAS FOUND AND HAD DRIPPED ON IV PUMPS AND ON THE FLOOR. THEY NOTED THAT SPIKE IN BAG WAS OUT SLIGHTLY, SO THEY PUSHED SPIKE INTO BAG A LITTLE MORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824848 ↗MalfunctionNov 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING EPI TUBING FROM THE PUMP I NOTICED THE TUBING WAS WET AND THE TUBING WAS SQUIRTING EPI OUT OF THE TUBING. QUANTITY AFFECTED: (B)(4) EA WAS THERE INJURY? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23587119 ↗MalfunctionNov 3, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE MEDICATION WAS LEAKING OUT OF THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452709 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT IVIG LEAKED OUT THROUGH A HOLE IN THE TUBING. HOLE WAS NOT APPARENT WHEN RN PRIMED THE TUBING, BUT SEVERAL HOURS AFTER ADMINISTRATION COMPLETED, RN NOTED PUDDLE OF LIQUID ON THE FLOOR. AFTER FURTHER INSPECTION SHE FOUND A HOLE IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22768479 ↗MalfunctionJul 25, 2025Break; Break
IT WAS REPORTED THAT THE BD ALARIS PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REGULAR LARGE BORE IV TUBING WAS BEEPING AIR IN LINE. I PULLED THE TUBING OUT OF THE PUMP TO REMOVE THE AIR BUBBLES, AND WHEN I ATTEMPTED TO FLICK THE TUBING, A SMALL HOLE WAS SEEN THAT SQUIRTED FLUIDS. TUBING WAS REMOVED AND REPLACED WITH UNDAMAGED TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22612656 ↗MalfunctionJul 8, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT AIR NOTICED IN LINE ON LARGE VOLUME ALARIS "PUMP INFUSION SET" WHEN TROUBLE SHOOTING AIR, TUBING DISCONNECTED FROM BLUE CASSETTE (THE PORTION THAT LOADS INTO PUMP) AND BEGAN LEAKING TPN. THE LINE IS CUT AND TIED IN A KNOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22435392 ↗MalfunctionJun 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22237553 ↗MalfunctionJun 16, 2025Break; Break
IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE SPIKE FROM THE INFUSION PUMP SET BROKE OFF INSIDE FLUID BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22213501 ↗MalfunctionMay 29, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22110586 ↗MalfunctionMay 27, 2025Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT CLINICIANS FIND THE IV SET IS STIFFER AND AIR GETS TRAPPED IN CERTAIN SECTIONS OF THE IV SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22092937 ↗MalfunctionMay 27, 2025Defective Component; Material Twisted/Bent; Defective Component; Material Twisted/Bent
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22092860 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.