Alaris 11426964Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10885403232367), received between Oct 24, 2018 and Mar 26, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 19, 2026Open, Classified

   Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

   Z-3080-2026 · Root cause: Device Design · FDA record ↗

2. Oct 11, 2023Open, Classified

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

   Z-0349-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Separation Problem

  IT IS REPORTED, CONNECTOR CAME UNATTACHED FROM THE TUBING. MAKING IT UNABLE TO CONNECT THEM TOGETHER. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700336 ↗
• MalfunctionNov 21, 2025Material Separation; Connection Problem; Material Separation; Connection 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 THE BOTTOM HALF OF THE TUBING BROKE OFF, BUT THE TUBING WAS CLAMPED WHICH DIDN'T RESULT IN A SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623613 ↗
• MalfunctionMay 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT LEAKS AS DESCRIBED BELOW AND ALSO TEAM MEMBERS FORGETTING TO ADD THE TEXIUM BECAUSE IT IS NOT PART OF TYPICAL WORKFLOW WHICH INCREASES RISK OF EXPOSURE BECAUSE IT BREAKS THE CLOSED SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013594 ↗
• MalfunctionMay 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT LEAKS AS DESCRIBED BELOW AND ALSO TEAM MEMBERS FORGETTING TO ADD THE TEXIUM BECAUSE IT IS NOT PART OF TYPICAL WORKFLOW WHICH INCREASES RISK OF EXPOSURE BECAUSE IT BREAKS THE CLOSED SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013580 ↗
• MalfunctionMar 26, 2024Defective Component; Defective Component

  ADDITIONAL INFORMATION: 1.PLEASE PROVIDE THE DATE OF EVENT. 3/5. 2. PLEASE DESCRIBE THE EVENT ELABORATELY. NURSE WENT TO PUNCTURE AN IV BAG OF NS AND THE BAG SPIKE BROKE IN NURSE HAND WHILE TRYING TO PUSH THROUGH THE BAG SPIKE. ALL MATERIAL DISCARDED. 3. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? YOU HAVE IV LINE AND BAG WITH REF NUMBER 4. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? YES IT WAS IN FRONT OF A PT AND BY RN. 5. PLEASE CONFIRM THE NUMBER OF OCCURRENCES: 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976691 ↗
• MalfunctionJan 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE LOW SORBING INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: EVENT DETAILS: ¿DURING THE CHEMO INFUSION OF ALEMTUZUMAB, RN MONITORING THE PATIENT AT BEDSIDE NOTICED A SLOW LIQUID DRIPPING FROM THE BOTTOM OF THE CHANNEL OF ALEMTUZUMAB. INFORMED ANOTHER RN TO DOUBLE CHECK THE LEAK. ALEMTUZUMAB STOPPED AND INFORMED PATIENT, PHARM D, APN. INSTRUCTED BY INPATIENT PHARMACY TO RETURN REMAINING MEDICATION. CHEMO SPILL CLEANED IN ACCORDANCE WITH POLICY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595738 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE LOW SORBING INFUSION SET SEPARATED AND LEAKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: GOOD MORNING. ON 9/17/2023, WE HAD A SAFETY EVENT REPORTED FOR (BD ALARIS PUMP INFUSION SET LOW SORB TUBING). LET¿S IDENTIFY THIS AS BD 248, AS A REFERENCE NUMBER. THE TUBING HAS BEEN DISCARDED. BASED ON THE INFORMATION PROVIDED BELOW, COULD YOU START A PRODUCT QUALITY REPORT? EVENT DETAILS: ¿LOW SORB IV TUBING. WHEN I WAS CIRCLE PRIMING CHEMO AT MED ROOM AT XXX POD. THE IV TUBING POPPED AT FILLING CHAMBER, SPILLED OUT CHEMO ABOUT 10CC. USED CHEMO SPILL KIT TO CLEAN THAT AREA. AROUND 5 CC SPILL HAPPENED ON MY LEFT HAND, WHICH WAS DOUBLE GLOVED. SPILLING CHAMBER COULDN'T HOLD PRESSURE DURING CIRCLE PRIME. I JUST PUSHED TWO TIMES. WHEN I WAS DOING SECOND TIME IT POPPED OUT.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865876 ↗
• MalfunctionSep 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE LOW SORBING INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: EVENT DETAILS: ¿WHILE PRIMING LOW-SORB (NON-PVC) SHORT SET OF IV TUBING WITH SALINE, NOTED LEAK AT TOP OF DRIP CHAMBER.¿ BD 244: REPORTED DATE: 09/05/2023; EVENT DATE: 09/05/2023; ITEM NUMBER: 11426964; LOT NUMBER: 22115764; ITEM RETAINED IN DEFECT DEPOT?: NO; PICTURE: YES, ATTACHED; PATIENT HARM: NONE; AREA: AMBULATORY TREATMENT CENTER ¿ WOODLANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17790598 ↗
• MalfunctionFeb 15, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING DISCONNECTED FROM THE BD ALARIS¿ PUMP MODULE LOW SORBING INFUSION SET WHILE CLAMPING IT AT THE END OF THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A NURSE REPORTED ANOTHER INSTANCE OF THE TUBING BREAKING, THIS TIME AT THE END OF THE INFUSION ((B)(6) 2023 ): THE TUBING SUDDENLY GOT DISCONNECTED WHILE I WAS CLAMPING IT. THANKFULLY THERE WAS NO LEAK AS MEDICATION WAS FINISHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383762 ↗
• MalfunctionAug 9, 2022Break; Break

  IT WAS REPORTED THAT THE BD ALARIS¿ LVP 20D LOW SORB EXPERIENCED DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN WE WERE IN SWEDISH ARNOLD PAVILION YESTERDAY THEIR PHARMACY REPORTED THAT THEY HAD A CHEMO SET BREAK OFF RIGHT NEXT TO THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191700 ↗
• MalfunctionJul 22, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD ALARIS¿ LVP 20D LOW SORB EXPERIENCED LABELING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING ISSUE, TUBING IS MISLABELED, NOT THE RIGHT TUBING AND NO FILTER. THE TUBING IS LABELED AS 10010454, BUT WHAT WAS ACTUALLY RECEIVED WAS PRODUCT # 11426964.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089728 ↗
• MalfunctionAug 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE GEM V/NV 20DP LOW SORBING NO PORTS EXPERIENCED LEAKAGE AT CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE NOTICED DRUG ON THE FLOOR AND DRIPPING FROM THE TUBING (ALARIS #11426964) TOWARDS THE END OF THE INFUSION. CHEMO WAS ADMINISTERED AT APPROX 500 ML/ HR WITH AN ALARIS PUMP. CUSTOMER FELT THAT THE LEAK OCCURRED BETWEEN THE SPIN COLLAR CONNECTION AND THE PHASEAL OPTIMA INJECTOR (PRODUCT 515057), WHICH HAD BEEN ATTACHED IN PHARMACY. ALL PHARMACY STAFF HAS BEEN TRAINED AND RETRAINED IN HOW TO CONNECT THESE COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375567 ↗
• MalfunctionAug 5, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE AS LVP 20D LOW SORB TUBING SET BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PARTICULATE MATTER IN IV TUBING SET. SAW BEFORE IV SET USED ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283654 ↗
• MalfunctionMay 19, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE AS LVP 20D LOW SORB HAD BLACK FOREIGN MATTER AROUND THE SPIKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PHARMACY TECHNICIAN NOTICED TODAY A BLACK AREA AROUND THE SPIKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853130 ↗
• MalfunctionMay 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP 20D LOW SORB CONNECTOR BROKE AND LEAKED CHEMO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 11426964. BATCH/LOT #: UNKNOWN. IT WAS REPORTED THAT THE CONNECTOR BROKE APART FROM IV LINE AND CHEMO BEGAN TO LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787863 ↗
• MalfunctionFeb 11, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A "RED SPRAY" SUBSTANCE WAS FOUND IN THE AS LVP 20D LOW SORB TUBING CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HELLO, WE HAVE NOTICED SOME RED SPRAY SUBSTANCE IN THE CHAMBER OF THE TUBING TODAY."

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

  MAUDE report 11313768 ↗
• MalfunctionFeb 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE GEM V/NV 20DP LOW SORBING NO PORTS EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 11426964, BATCH NO: 20085878. WE HAVE NOTICED SOME RED SPRAY SUBSTANCE IN THE CHAMBER OF THE TUBING TODAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11264057 ↗
• MalfunctionNov 2, 2020Fungus in Device Environment; Device Contamination with Chemical or Other Material; Fungus in Device Environment; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLACK FOREIGN MATTER, POSSIBLY THOUGHT TO BE MOLD, WAS FOUND ON THE AS LVP 20D LOW SORB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY ONE OF OUR PHARMACY TECHS NOTICED SOMETHING BLACK ON ONE OF OUR TUBING SETS WHEN HE REMOVED THE CAP. WE FOUND ONE OTHER SET WITH THE SAME ISSUE. THIS IS ON THE BD ALARIS PUMP INFUSION SET REF 11426964. I AM NOT POSITIVE ON THE LOT NUMBER AS THESE WERE REMOVED AND PREPPED FOR CHEMOTHERAPY ADMINISTRATION EARLIER IN THE DAY AND THE PACKAGING WAS DISCARDED. THE LOT# I HAVE ON THE SHELF IS (10)20077096. WE HAVE LOOKED AT ALL THE OTHER SETS THAT WE HAVE AND HAVEN¿T FOUND ANY OTHERS WITH THIS ISSUE. IT IS HARD TO TELL IF THIS IS SOME SORT OF MANUFACTURING DEFECT OR SOME KIND OF GROWTH.

  Patient problems: No Patient Involvement

  MAUDE report 10775123 ↗
• MalfunctionDec 18, 2019Difficult to Open or Close; Difficult to Open or Close

  THE REPORTED FEEDBACK SUGGESTS THAT THE FAILURE OF SAFETY CLAMP FITMENT ACTIVATION ON REMOVING SET FROM LVP CHANNEL POST USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9489702 ↗
• MalfunctionDec 12, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTED FEEDBACK SUGGESTS THAT THERE IS A FAILURE OF SAFETY CLAMP ON IV ADMINISTRATION SET TO BE ACTIVATED ON REMOVAL OF LINE FROM ALARIS SYSTEM LVP CHANNEL. FROM THE REPORTED INFORMATION THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9460985 ↗
• MalfunctionNov 21, 2018Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, ¿THE ETOPOSIDE STARTED INFUSING, AND STAFF STAYED WITH PATIENT FOR A FEW MINUTES, THEN WENT TO GET PATIENT A PAIR OF (B)(6) PANTS, CAME BACK AND NOTICED THAT THE CHEMO TUBING HAD A SLOW LEAK/DRIP COMING FROM MODULE, SO STAFF GOWNED, AND GLOVED AND STOPPED INFUSION IMMEDIATELY, OPENED TWO CHEMO SPILL KITS, PUT ON APPROPRIATE ATTIRE, DISCONNECTED PATIENT FROM CHEMO TUBING, USED CHEMO SPILL KIT TO CLEAN AREA OF FLOOR AND DISPOSED OF ANYTHING THAT CAME INTO CONTACT WITH THE CHEMO INTO CHEMO BAG. UNFORTUNATELY IT WAS UNKNOWN HOW MUCH CHEMO LEAKED TO THE FLOOR AND PATIENT WILL RESUME CHEMO TOMORROW AT THE SCHEDULED TIME." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2018 WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8095311 ↗
• MalfunctionOct 24, 2018Leak/Splash; Insufficient Flow or Under Infusion

  THE ETOPOSIDE STARTED INFUSING, AND STAFF STAYED WITH PATIENT FOR FEW MINUTES, THEN WENT TO GET PATIENT A PAIR OF JOHNNY PANTS, CAME BACK AND NOTICED THAT THE CHEMO TUBING HAD A SLOW LEAK/DRIP COMING FROM MODULE, SO STAFF GOWNED, AND GLOVED AND STOPPED INFUSION IMMEDIATELY, OPENED TWO CHEMO SPILL KITS, PUT ON APPROPRIATE ATTIRE, DISCONNECTED PATIENT FROM CHEMO TUBING, USED CHEMO SPILL KIT TO CLEAN AREA OF FLOOR AND DISPOSED OF ANYTHING THAT CAME INTO CONTACT WITH THE CHEMO INTO CHEMO BAG. UNFORTUNATELY IT WAS UNKNOWN HOW MUCH CHEMO LEAKED TO THE FLOOR AND PATIENT WILL RESUME CHEMO TOMORROW AT THE SCHEDULED TIME.

  Patient problems: Underdose

  MAUDE report 7999090 ↗