Alaris 2204-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10885403199363), received between Sep 25, 2018 and Sep 22, 2026 — classified as 59 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (20 reports).

3 FDA recall records name this device's identifier, 3 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. Aug 19, 2026Class IOpen, 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 · Recall details · FDA record ↗

2. Jul 8, 2025Class IOpen, Classified

   Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

   Z-2180-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Oct 11, 2023Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Excess Flow or Over-Infusion

  It was reported that the BD Alaris Pump Module Infusion Set had flow issues. The following information was provided by the initial reporter: Incident Report Details: Device: BD Alaris 8015 PC Unit. Serial Number: (b)(6). Date of Event: 29-Aug-2026. Time of Event: Unknown. Patient Involvement: Yes. Patient Harm: Unknown. Event Description: The BD Alaris 8015 PC Unit (S/N (b)(6)) was infusing medication to a patient. The customer reported that the medication was delivered faster than expected. The infusion was programmed to run over 1 hour, however, the infusion was reportedly completed in approximately 38 minutes. No additional information regarding the infusion setup, medication, programmed rate, volume to be infused (VTBI), alarm history, or device logs was provided at the time of reporting.

  Patient problems: Headache

  MAUDE report 50858507 ↗
• MalfunctionJun 10, 2026Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD ALARIS PUMP INFUSION SET'S TUBING MAY SEPARATE, LEAK, OR FAIL TO PRIME. WHEN THIS OCCURS: TREATMENT WILL BE DELAYED. THERE IS POTENTIAL FOR PATIENT BLOOD LOSS. THE COMPROMISED ADMINISTRATION SET PRESENTS A ROUTE FOR INFECTIOUS AGENTS. MEDICATION MAY SPILL, POTENTIALLY EXPOSING STAFF AND PATIENTS TO TOXIC MEDICATION (E.G., CHEMOTHERAPY AGENTS). ALSO, THE SPILL MAY PRESENT A FALL RISK. MEDICATION MAY BE WASTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453133 ↗
• MalfunctionJun 2, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY EXPERIENCED UNDER-INFUSION OF CHEMOTHERAPY MEDICATIONS WHEN USING GLASS BOTTLES AS WELL AS DURING SECONDARY INFUSIONS. ADDITIONALLY, IT WAS REPORTED THAT SECONDARY CHEMOTHERAPY INFUSIONS WERE PULLING FROM THE PRIMARY LINE DESPITE THE PRIMARY BAG BEING POSITIONED LOWER THAN THE SECONDARY BAG USING TWO HANGERS. BOTH THE PRIMARY AND SECONDARY BAGS CONTAINED 500 ML. THERE WAS PATIENT INVOLVEMENT HOWEVER OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25367848 ↗
• MalfunctionApr 20, 2026Leak/Splash; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925901 ↗
• MalfunctionApr 20, 2026Leak/Splash; Connection Problem

  IT WAS REPORTED THAT THE BD PHASEAL HAD A DISCONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:UNKNOWN. BATCH#:UNKNOWN. VERBATIM: PHARMACIST NOTED LEAKING AROUND THE PHASEAL AND THE SPIN COLLAR ON SEVERAL OCCASIONS, DID NOT SAVE PRODUCT. OVC REP WENT ON SIGHT ON 10/27/26 AND NOTED EDUCATION WAS NEEDED IN LOCKING THE PHASEAL BUT ALSO NOTED THAT THE SPIN COLLAR ON THE SET WAS "SLIPPING" AND CAUSING IT TO BECOME LOOSE. NO PATIENT INVOLVEMENT ADDITIONAL INFORMATION PROVIDED: 1. PLEASE PROVIDE THE BATCH# OR LOT# NUMBER FOR THE REPORTED PHASEAL PRODUCT? 2. PLEASE PROVIDE THE MATERIAL# OR REF# NUMBER FOR THE REPORTED PHASEAL PRODUCT? 3. KINDLY CONFIRM WHETHER YOU HAVE OBSERVED ANY ISSUES WITH THE TUBING PRODUCT, GIVEN THAT MATERIAL #10942011-04 (AS LVP 20D) HAS BEEN REFERENCED IN THE PIR COMPLAINT REPORT. IF AN ISSUE HAS BEEN IDENTIFIED, PLEASE PROVIDE A DETAILED ISSUE DESCRIPTION ALONG WITH THE APPLICABLE LOT NUMBER I DO NOT HAVE THIS INFORMATION. IT WAS A GENERAL OBSERVATION AND WE WERE TRYING TO FIGURE OUT WHY IT MAY BE HAPPENING. EDUCATION WAS PROVIDED BY BD REPRESENTATIVE AND WE WILL CONTINUE TO MONITOR. I WILL MAKE SURE TO RECORD THIS INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925892 ↗
• MalfunctionMar 12, 2026Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584159 ↗
• MalfunctionFeb 12, 2026Material Integrity Problem; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327449 ↗
• MalfunctionDec 23, 2025Disconnection; Activation, Positioning or Separation Problem; Disconnection; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT DISCONNECTION BETWEEN ALARIS TUBING AND OPTIMA INJECTOR LEADING TO CHEMO SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880408 ↗
• MalfunctionNov 21, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THEY ARE EXPERIENCING AIR IN LINE, BUBBLES, ONCE THEIR PRIMING SOLUTION HITS THE LITTLE PIECE WHERE TWO PIECES OF TUBING COME TOGETHER ABOVE THE PUMPING SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624904 ↗
• MalfunctionNov 10, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD A LOOSE COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ETOPOSIDE STARTED LEAKING SHORTLY AFTER INITIATION TODAY, AND IT LOOKED TO ME LIKE IT ORIGINATED FROM SOMEWHERE AROUND THE BLUE PLASTIC PIECE IN THE LINE (CIRCLED BELOW). THERE WAS A DECENT AMOUNT OF LIQUID INSIDE THE PUMP CHANNEL AND DRIPPING OUT THE BOTTOM BUT EVERYTHING FROM THAT BLUE PLASTIC PIECE AND UPSTREAM WAS DRY. WE PULLED ON A LINE, AND IT DIDN¿T TAKE TOO MUCH STRENGTH TO DETACH THE STRETCHY TUBING FROM THE BOTTOM OF THE BLUE PIECE. THE NURSES SAID THEY HAVE TO STRETCH OUT THAT PART TO GET IT INTO THE PUMP CHANNEL SO THIS COULD JUST BE USER ERROR BUT WANTED TO LET YOU KNOW IN CASE THIS COME UP AGAIN. FOR WHAT IT¿S WORTH, THE NURSE SAID SHE¿S NEVER SEEN A LEAK ORIGINATE FROM THERE BEFORE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: IT IS A CHEMOTHERAPY DRUG. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513828 ↗
• MalfunctionSep 2, 2025Connection Problem; Separation Problem; Connection Problem; Separation Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT TUBING SET FELL APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929808 ↗
• MalfunctionAug 25, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT TUBING SET FELL APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887481 ↗
• MalfunctionAug 19, 2025Connection Problem; Connection Problem

  PHOTO + SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843045 ↗
• MalfunctionAug 18, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE ALARIS PUMP INFUSION SETS COMING APART AT THE POINT OF THE SLIDE CONNECTION - NOT AT THE ROLLER CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834998 ↗
• MalfunctionAug 14, 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 VERBATIMIT WAS REPORTED BY THE CUSTOMER THAT HERE WAS A SMALL HOLE IN THE PUMP SEGMENT OF IV LINE THAT RESULTED IN LEAKAGE OF MEDICATION ON THE PT AND ON THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810776 ↗
• MalfunctionJul 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING IT WAS REPORTED BY CUSTOMER THAT SHORT SETS THAT SNAPPED JUST BELOW THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22536831 ↗
• MalfunctionJul 3, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE LUERLOCK HAD SEPARATED FROM THE IV TUBING COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401263 ↗
• MalfunctionMay 29, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE ALARIS TUBING WE ARE USING HAS NOT BEEN ACTIVATING THE BLUE AND WHITE SAFETY CLAMP WHICH FITS IN THE PUMP CHANNEL. UPON REMOVAL FROM THE CHANNEL, THE CLAMP DOES NOT ACTIVATE SO ANYTHING IN THE TUBING RUNS TO THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109008 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT SECONDARY TUBING CONNECTOR SET BROKE WHEN CONNECTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896597 ↗
• MalfunctionNov 20, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET HAD OVER INFUSED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. PT WAS SCANNED MAGNESIUM WAS SCANNED INTO IHIS THEN CHANNEL A ON THE PUMP WAS SCANNED TUBING WAS PRIMED AND PLACED INTO THE CHANNEL ON SHORT TUBING PUMP WAS PROGRAMMED CORRECTLY. PUMP HAD THE CORRECT RATE AND DOSAGE UPON APPROVING THE PUMP TO RUN. THEN WHEN GOING IN AT 0630AM CHANNEL WAS BEEPING AND LINE WAS DRY AND THE MAG WAS COMPLETELY AND RAN OVER 20 MINUTES WHEN IT SHOULD HAVE GONE OVER 4 HOURS. ADDITIONAL INFO: 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? WAS THERE ANY LEAK DUE TO DAMAGE OR ELSE ANY LOOSE CONNECTION IN THE SET UP? NO LEAKAGE. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737226 ↗
• MalfunctionNov 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT IV TUBING SNAPPED IN HALF WHILE MEDICATION WAS INFUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674530 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT LEAKING CHEMOTHERAPY, HAD TO RESTART THE CHEMO AFTER THEY COMPLETED A CHEMO CLEAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664160 ↗
• MalfunctionOct 30, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. PATIENT RECEIVING IVIG WENT TO CHANGE BOTTLE SPIKED IT AND A PIECE OF THE RUBBER FROM THE TOP OF BOTTLE WENT INTO THE CHAMBER. STOPPED INFUSION AND CHANGED TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570881 ↗
• MalfunctionJul 23, 2024Free or Unrestricted Flow; Air/Gas in Device; Free or Unrestricted Flow; Air/Gas in Device

  MATERIAL # 2204-0007, BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT DURING BEGINNING OF INFUSION ALARM STATED AIR IN LINE, BUT WHEN CHECKED NO AIR WAS VISIBLE IN LINE. WHEN TUBING CHANGED NO ALARM SOUNDED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DURING BEGINNING OF INFUSION ALARM STATED AIR IN LINE, BUT WHEN CHECKED NO AIR WAS VISIBLE IN LINE. WHEN TUBING CHANGED NO ALARM SOUNDED. MODEL #: 2204-0007.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807192 ↗
• MalfunctionJul 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE INFUSION SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THE SHORT CLIP SHOWS THE CONNECTION AND PHARMACY TECH PULLING ON THE TUBING, THIS WAS NOT FORCEFUL, ALTHOUGH IT LOOKS THAT WAY IT CAME OUT EASILY. DAVID AND I REINFORCED PULLING BACK THE SPIN COLLAR TO EXPOSE THE MALE SECTION OF THE TUBING, INSERTING WITH ¼ TURN AND THEN THE SPIN COLLAR TIGHTENING. THEY FOLLOWED AND ADVISED THEY HAVE BEEN DOING THIS ALL ALONG. WE WATCHED PHARMACY TECHS FROM BOTH ORGANIZATIONS WITH PHARMACIST PRESENT ALSO IN BOTH LOCATIONS. WE WATCHED THEIR SET UP, PRIMING AND DOUBLE CHECKS. THE VIDEOS WILL SHOW SOME MANIPULATION TO SHOW THE FAILURE, BUT THEY REASSURED THIS WAS NOT THE STANDARD PRACTICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697573 ↗