Alaris, SmartSite 2465-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10885403221941), received between Jul 12, 2018 and Jul 6, 2026 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 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 RN WENT TO THE PATIENT'S BEDSIDE TO PERFORM A DRESSING CHANGE AND NOTICED THE CHEMO ADMINISTRATION SET WITH FILTER WAS LEAKING A SMALL AMOUNT OF FLUID ONTO THE PATIENT'S BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25727891 ↗
• MalfunctionJul 6, 2026Crack

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN NOTICED THE PATIENT'S IV EPOCH BAG WAS LEAKING. UPON CLOSER INSPECTION, THE RN NOTICED THE 0.2 MICRON FILTER WAS CRACKED. THE IV EPOCH BAG WAS BROUGHT DOWN TO THE CENTRAL PHARMACY, AND THE CHEMO TECHNICIAN REPLACED THE INFUSION SET. ITEM DESCRIPTION: SET CHEMO TUBING LOW SORB W/0 MFG #: 2465-0007 LOT #: 25116247 QUANTITY AFFECTED: 1 EA. WAS THERE INJURY: REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25726051 ↗
• MalfunctionNov 7, 2025Break; Material Separation; Break; Material Separation

  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 TUBING BROKE FROM DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497736 ↗
• MalfunctionAug 13, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM PATIENT WAS WALKING THE HALL WITH MOM AND CHEMOTHERAPY CONNECTOR BECAME DISCONNECTED AT THE CHEMO LINE SIDE THAT COMES FROM PHARMACY. BLOOD WAS DRIPPING OUT OF THE LINE FROM THE PATIENT¿S PORT, ONTO THE PATIENT AND ALL OVER THE FLOOR AS THE TWO CHEMO PIECES (CONNECTOR AND INJECTOR) WERE STILL CONNECTED, WITH THE BLUE TURTLENECK PIECE AROUND THEM, LEAVING THE LINE COMPLETELY OPEN ON THE PATIENT¿S SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798086 ↗
• MalfunctionAug 13, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM PATIENT¿S MOTHER REACHED OUT TO INFORM THAT THE PATIENT SEEMED IN PAIN AROUND PORT SITE. UPON CHECKING THE PORT RN NOTICED THAT THE PORT WAS LEAKING AND PATIENT HAD MODERATE SWELLING TO THE SITE. BLINATUMOMAB WAS STOPPED AND TEAM MADE AWARE. IT WAS NOTED THAT PATIENT IS A VERY ACTIVE INFANT THAT DE-ACCESSES THEMSELF OFTEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796224 ↗
• MalfunctionAug 13, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMPATIENT DISCONNECTED THEIR CHEMOTHERAPY TUBING. THEY HAD THE LINES TWISTED SECURELY ON AND THE BLUE CHEMO GUARD COVER ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795326 ↗
• MalfunctionAug 13, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM WHILE AT BEDSIDE RN OBSERVED BLINATUMOMAB TUBING MAKING A POPPING SOUND AND BECOMING DISCONNECTED. BLOOD DROPS WERE PRESENT ON THE FLOOR FROM THE PORT. TUBING BECAME DISCONNECTED FROM ABOVE TURTLENECK. RN NOTIFIED CHARGE NURSE. AT THE TIME OF BAG CHANGE, SAME CONNECTOR WAS NOT PROPERLY CONNECTED AND BECAME DISCONNECTED PRIOR TO HANGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795324 ↗
• MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM FEMALE END OF THE CHEMOTHERAPY CONNECTOR DISCONNECTED FROM THE BLINATUMOMAB TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795323 ↗
• MalfunctionAug 13, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM RN WALKED INTO THE PATIENTS ROOM AND NOTICED THE OPTIMA INJECTOR WAS DISCONNECTED FROM THE PATIENT¿S CHEMOTHERAPY. PT WAS FOUND LYING QUIETLY IN THE BED PLAYING WITH IPAD AND STATED THAT ¿THEY HAD NOT MOVED OR PULLED ON THE LINE¿. RN IMMEDIATELY RECONNECTED THE LINE AND RESUMED CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795319 ↗
• MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM PATIENT WAS ACCOMPANIED BY PARENTS TO THE PLAYROOM AREA. RN PASSED BY AND PATIENT¿S PARENTS NOTIFIED THAT THE PATIENT¿S CONNECTOR FOR PATIENT¿S BLINATUMOMAB BECAME DISCONNECTED. RN NOTED THAT THE DISCONNECTION OCCURRED ABOVE THE TURTLENECK OF THE TUBING. RN ENSURED THE PATENCY OF THE PORT AND CONNECTED PATIENT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795318 ↗
• MalfunctionAug 13, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM RN WAS IN THE ROOM WHEN PATIENT¿S CHEMOTHERAPY LINE DISCONNECTED FROM THE SPOT ABOVE THE BLUE HUB TO COVER THE MALE/FEMALE PIECE OF THE LINE. PATIENT WAS SITTING CALMY ON FAMILY MEMBER¿S LAP. RN IMMEDIATELY PAUSED THE INFUSION AND CLAMPED THE CENTRAL LINE AND CALLED FOR CHARGE NURSE. RN RECONNECTED THE LINE AFTER CHARGE NURSE CAME IN AND ASSESSED THE SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795317 ↗
• MalfunctionAug 13, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM RN FOUND PATIENT OPTIMA INJECTOR WAS DISCONNECTED FROM THE PATIENT¿S CHEMOTHERAPY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795127 ↗
• MalfunctionMay 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TUBING BROKE DURING BLINCYTO INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041220 ↗
• MalfunctionMar 31, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM WE HAVE HAD MULTIPLE INSTANCES OF THE CONNECTOR BECOMING LOOSE AND/OR LEAKING AT THE LUER LOCK CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735747 ↗
• MalfunctionDec 4, 2024Break; Break

  MATERIAL #:2465-0007. BATCH#: 24055589. IT WAS REPORTED BY CUSTOMER THAT LEAKING TUBING/BROKEN TUBING. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. LEAKING TUBING/BROKEN TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844512 ↗
• MalfunctionDec 3, 2024Leak/Splash; Leak/Splash

  MATERIAL #:2465-0007, BATCH#:24055589. IT WAS REPORTED BY CUSTOMER THAT WHEN MEDICATION WAS MADE/MIXED BY PHARMACY AND TUBING PRIMED WITH 0.9%NS AND SENT OUT TO THE NURSE FOR ADMINISTRATION. WHEN SHE WENT TO HANG THE TUBING, IT SNAPPED, AND DRUG LEAKED A SMALL AMOUNT VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT: BD ALRIS PUMP INFUSION SET SMART SITE BAG ACCESS NON-VENTED ¿ REF (B)(4) LOT: (10)24055589. EXPIRATION DATE: 05/27/27. DRUG INVOLVED: OPDIVO AND SODIUM CHLORIDE 100 ML. ISSUE: THE MEDICATION WAS MADE/MIXED BY PHARMACY AND TUBING PRIMED WITH 0.9%NS AND SENT OUT TO THE NURSE FOR ADMINISTRATION. WHEN SHE WENT TO HANG THE TUBING IT SNAPPED AND DRUG LEAKED A SMALL AMOUNT. I HAVE THE TUBING AVAILABLE FOR RETURN FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839114 ↗
• MalfunctionDec 3, 2024Leak/Splash; Leak/Splash

  MATERIAL # 2465-0007 BATCH # 24075242. IT WAS REPORTED BY CUSTOMER THAT IN THE LAST WEEK, THEY EXPERIENCED THREE INSTANCES OF FAULTY IV SETS WHERE CYTOTOXIC CHEMO MEDICATION LEAKED FROM THE BAG ACCESS PORT ON THE SIDE OF THE BAG SPIKE. ONE INSTANCE WAS CAUGHT WHEN THE TECHNICIAN HAD JUST FINISHED COMPOUNDING THE MEDICATION AND WAS STILL IN THE IV HOOD. THE OTHER TWO INSTANCES WERE NOTICED WHEN THE IV SET WAS LEAKING FROM THE BAG ACCESS PORT AS THEY WERE ABOUT TO HANG THE MEDICATION FOR THE PATIENT. TO FIX THIS, THEY HAD TO SWITCH THE TUBING ON THESE THREE CHEMO PREPARATIONS BY BRINGING THEM BACK INTO THE IV ROOM. THE FAILED IV SETS WERE REF (B)(4) (WHICH FAILED TWICE THIS WEEK) AND (B)(4) (WHICH FAILED ONCE THIS WEEK). THEY REACHED OUT TO ANOTHER SANFORD SITE, WHICH MENTIONED HAVING HAD THIS ISSUE IN THE PAST AND HAD STARTED USING AN ONGUARD SPIKE ADAPTOR. THEY BEGAN USING THIS ADAPTER TODAY AS WELL BUT STILL EXPERIENCED LEAKAGE FROM THE BAG ACCESS PORT OF THE BD SET (10015862), EVEN THOUGH THAT PORT WAS NEVER UTILIZED DURING COMPOUNDING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE FAILED IV SETS ARE REF (B)(4) (OCCURRED TWICE THIS WEEK) AND (B)(4) (FAILED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834148 ↗
• MalfunctionDec 7, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH VERBATIM: BD ALARIS PUMP INFUSION SET REF: 2465-0007 LOT: (10)23085144. CLINICAL REPORTED THAT THE TUBING NOTICED TO BE BROKEN WITH HOLE. THE TUBING WAS NOT ABLE TO BE SEQUESTERED. ACCORDING TO THE PHARMACY- THE DOSE WITH CRACKED LINE HAS ALREADY BEEN PLACED IN A CHEMOTHERAPY WASTE BIN. WE NEEDED TO DISPOSE OF IT AS IT WOULD BE HARMFUL IN THE EVENT OF ANY EMPLOYEE EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287870 ↗
• MalfunctionApr 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD ALARIS PUMP INFUSION SET SMARTSITE BAG ACCESS NON-VENTED 0.2 MICRON FILTER LOW SORBING TUBING (REF 2465-0007) LOT NUMBER (10)21116110) THE INFUSION SET WAS INFUSING A CHEMOTHERAPY DRUG FOR ~20 HOURS WHEN WE NOTICED THAT ON THE BACK OF THE FILTER THERE WAS SOME FLUID OUTSIDE OF THE TUBING SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773077 ↗
• MalfunctionApr 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 OF THE BD ALARIS¿ LVP SS BAG 20D LOW SORB SS 0.2M WERE LEAKING AT THE FILTER SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 TUBING SET WERE LEAKING AT THE FILTER SITE.

  Patient problems: Chemical Exposure

  MAUDE report 16765634 ↗
• MalfunctionJan 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS¿ LVP SS BAG 20D LOW SORB SS 0.2M COMPONENTS SEPARATED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD RECENT INCIDENTS OF BAG SPIKES (ADMINISTRATION SETS FOR BD ALARIS PUMPS) FALLING OUT OF THE IV PORT AND EXPOSING NURSES TO DRUG RESIDUE. NURSES WERE SPLASHED WITH DRUG RESIDUE UPON DIFFERENT INCIDENTS OF DRUG ADMINISTRATION. EXAMPLES WAS NURSING FLUSHING THE LINE AND HANGING BAGS FOR ADMINISTRATION. ITS SEEMS THE PORTS ARE NOT FORMING A SECURE HOLD WITH THE IV ADMINISTRATION SETS.¿ ¿ WAS THERE ANY MEDICAL INTERVENTION NEEDED? NO, OCCUPATIONAL MEDICINE CONSULTED, RN INSTRUCTED TO WASH IMPACTED AREA WITH SOAP AND WATER AND CHANGE SCRUBS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118075 ↗
• MalfunctionMar 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING FROM THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13828848 ↗
• MalfunctionFeb 1, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED WHEN USING THE BD ALARIS LVP SS BAG 20D LOW SORB SS 0.2M, THE USER EXPERIENCED AN OCCLUDED PRODUCT. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE HAVE A QUESTION ABOUT FILTER TUBING WITH ERBITUX. HAVE YOU HEARD ANY PROBLEMS WITH THE LINES FAILING "PUMP OCCLUDED" THIS IS THE SECOND TIME THIS HAS HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418627 ↗
• MalfunctionOct 28, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING INFUSION SET ADAPTER SEPARATED FROM THE TUBING AND CAUSED CHEMO TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAD A CHEMO RN CALL DOWN THIS EVENING TO NOTIFY ME THAT THE CLOSED SYSTEM ADAPTER THAT CONNECTS THE TUBING TO THE BAG HAS BEEN POPPING OFF, THUS CAUSING CHEMO LEAKS. I KNOW THIS HAPPENED WITH A PATIENT LAST WEEK WHERE ~2/3 OF THE BAG LEAKED AND THE NEXT DAY WE RE-MADE THIS CHEMO. TODAY IT WAS CAUGHT SOON ENOUGH WHERE NO RE-MAKING WAS NECESSARY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715776 ↗
• MalfunctionSep 23, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED GEM 20DP 0.2MF LOW SORBING DEHP FREE WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OCCLUDED DURING INFUSION"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523083 ↗