Alaris, SmartSite C24101ERecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10885403235528), received between Jan 7, 2019 and Jun 12, 2023 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (22 reports).

1 FDA recall record name this device's identifier, 1 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 16, 2026.

Recalls naming this device

1. Sep 11, 2025Open, 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-0035-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ALARIS¿ LVP 20D DEHP AMBER SS 0.2M THERE WAS A CLOG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS ADDITIONAL BD ALARIS IV OCCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108456 ↗
• MalfunctionJun 6, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT UNSPECIFICED NUMBER OF BD ALARIS PUMP MODULE SMARTSITE AMBER INFUSION SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT LIPIDS ARE NOT PRIMING PAST THE FILTER. AS WE ARE SEEING SUCH AN INFLUX IN THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075937 ↗
• MalfunctionJun 6, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALARIS¿ PUMP MODULE SMARTSITE¿ AMBER INFUSION SETS WERE BLOCKED WHILE TRYING TO PRIME LIPIDS PAST THE FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE BEEN RECEIVING MULTIPLE PRODUCTS BACK FROM THE SITES STATING THAT THE LIPIDS WILL NOT PRIME PAST THE FILTER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074986 ↗
• MalfunctionMay 18, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 2 BD ALARIS¿ PUMP MODULE SMARTSITE¿ AMBER INFUSION SETS WERE BLOCKED AND WOULDN'T PRIME PAST THE FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SET IS NOT PRIMING PAST THE FILTER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959245 ↗
• MalfunctionMay 19, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A HOLE WAS FOUND IN THE AS LVP 20D DEHP AMBER SS 0.2M TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS BROUGHT TO MY ATTENTION THIS WEEK THAT WE RECEIVED A MED AMBER SET WITH A HOLE IN THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853252 ↗
• MalfunctionMar 10, 2021Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE AIR-IN-LINE ALARM SOUNDED REPEATEDLY DURING USE OF THE AS LVP 20D DEHP AMBER SS 0.2M WITH "INFLECTRA" AT LOW FLOW RATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE REPORTED "AIR IN LINE" ALARMS REPEATEDLY, EVEN AFTER CHANGING PUMPS. SHARED THAT ALARMS OCCURRED DURING LOW FLOW RATES (10, 20, AND 40 ML/HR) BUT NOT AT HIGH FLOW RATES (250 ML/HR). MEDICATION BEING INFUSED (INFLECTRA) WAS A STEP UP".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458121 ↗
• MalfunctionJan 9, 2021Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT AS LVP 20D DEHP AMBER SS 0.2M HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: C24101E BATCH/LOT # 20016400. IT WAS REPORTED THAT THEY ARE EXPERIENCING AIR IN LINE EVERY DAY. VERBATIM: REPORT FROM BEDSIDE NURSE: WE HAVE BEEN GETTING "AIR IN LINE" EVERYDAY. YESTERDAY, THERE WAS 1 1/2" OF AIR IN THE LINE, ABOUT 16 HOURS AFTER I HAD HUNG IT. I AM 100% SURE THAT EACH NIGHT WHEN I HUNG THE TPN THAT THERE WAS NO AIR IN THE LINE. I HAVE NEVER HAD THIS HAPPEN BEFORE, SO CONSISTENTLY. THIS IS OCCURRING IN THE PUMP SEGMENT PORTION OF THE TUBING. REQUESTING INVESTIGATION TO CONFIRM THAT PRODUCT IS MADE TO SPECIFICATION. THIS IS ONLY HAPPENING ON THIS PATIENT AND PUMPS HAVE BEEN INVESTIGATED WITH NO ISSUES FOUND. UNABLE TO DETERMINE WHAT ABOUT THIS LINE OR SETUP IS CAUSING ISSUE FOR ONLY THIS PATIENT WHEN SIMILAR SETUPS ARE NOT EXPERIENCING ANY ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11143851 ↗
• MalfunctionAug 24, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP 20D DEHP AMBER SS 0.2M TUBING CAME APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: C24101E, BATCH (LOT) NO: 19106851. IT WAS REPORTED THAT THE TUBING CAME APART AT THE DISTAL END OF THE PIECE THAT GOES INTO THE ALARIS PUMP. ADDITIONAL INFORMATION (CUSTOMER RESPONSE) 10-AUG-2020: 1. WHAT WAS THE DATE AND TIME OF THE EVENT? ON (B)(6) 2020, 4:30 PM. 2. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/SETUP OR WHEN TAKEN OUT OF PACKAGE? DURING PREPARATION NOT ATTACHED TO PATIENT. 3. IF PATIENT INVOLVEMENT; WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT? NO, PATIENT INVOLVEMENT. 4. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: NO. 5. EXPOSURE TO BLOOD/BODILY FLUID / IV SOLUTION? IF YES, PLEASE EXPLAIN: NO.

  Patient problems: No Patient Involvement

  MAUDE report 10444542 ↗
• MalfunctionAug 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING TPN, THE FILTER AIR VENT LEAKED. THE LEAK WAS DISCOVERED AFTER THE NEW TPN BAG AND TUBING WERE HUNG BUT DID NOT INVOLVE A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8913589 ↗
• MalfunctionJul 19, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AN UNSPECIFIED IV MEDICATION BAG WAS FOUND TO BE EMPTY AFTER BEING INITIATED BY THE PREVIOUS SHIFT. UPON ASSESSMENT IT WAS FOUND THAT THERE WAS A HOLE LOCATED IN THE UPPER PORTION OF THE TUBING SET.

  Patient problems: No Information

  MAUDE report 8807538 ↗
• MalfunctionJul 19, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AN DURING A TPN INFUSION IV BAG WAS FOUND TO BE EMPTY AFTER BEING INITIATED BY THE PREVIOUS SHIFT IN THE PICU DEPARTMENT. UPON ASSESSMENT IT WAS FOUND THAT THERE WAS A HOLE LOCATED IN THE UPPER PORTION OF THE TUBING SET.

  Patient problems: No Information

  MAUDE report 8807535 ↗
• MalfunctionMar 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A SITE VISIT BY A BD REPRESENTATIVES, THE STAFF REPORTED ISSUES SINCE (B)(6) 2018 WITH TPN FILTERS LEAKING AT VARIOUS TIMES WITHIN 45 MINS TO 90 HRS. OF A TPN INFUSION. IT WAS REPORTED THAT THE TPN IS CHANGED EVERY 96 HRS.,THE FACILITY IS USING MULTIPLE MANUFACTURER DISPOSABLES. THERE WAS NO REPORTED PATIENT HARM. THE EVENTS ARE OCCURRING IN MULTIPLE UNITS; HEM/ONC/BMT, BURN UNIT, NEUROSURGERY, PLASTIC SURGERY, TRAUMA UNIT, PICU, AND ENT PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8440214 ↗
• MalfunctionMar 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A SITE VISIT BY A BD REPRESENTATIVES, THE STAFF REPORTED ISSUES SINCE (B)(6) 2018 WITH TPN FILTERS LEAKING AT VARIOUS TIMES WITHIN 45 MINS TO 90 HRS. OF A TPN INFUSION. IT WAS REPORTED THAT THE TPN IS CHANGED EVERY 96 HRS., THE FACILITY IS USING MULTIPLE MANUFACTURER DISPOSABLES. THERE WAS NO REPORTED PATIENT HARM. THE EVENTS ARE OCCURRING IN MULTIPLE UNITS; HEM/ONC/BMT, BURN UNIT, NEUROSURGERY, PLASTIC SURGERY, TRAUMA UNIT, PICU, AND ENT PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8440154 ↗
• MalfunctionMar 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A SITE VISIT BY A BD REPRESENTATIVES, THE STAFF REPORTED ISSUES SINCE (B)(6) 2018 WITH TPN FILTERS LEAKING AT VARIOUS TIMES WITHIN 45 MINS TO 90 HRS. OF A TPN INFUSION. IT WAS REPORTED THAT THE TPN IS CHANGED EVERY 96 HRS.,THE FACILITY IS USING MULTIPLE MANUFACTURER DISPOSABLES. THERE WAS NO REPORTED PATIENT HARM. THE EVENTS ARE OCCURRING IN MULTIPLE UNITS; HEM/ONC/BMT, BURN UNIT, NEUROSURGERY, PLASTIC SURGERY, TRAUMA UNIT, PICU, AND ENT PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439909 ↗
• MalfunctionMar 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A SITE VISIT BY A BD REPRESENTATIVES, THE STAFF REPORTED ISSUES SINCE NOVEMBER 2018 WITH TPN FILTERS LEAKING AT VARIOUS TIMES WITHIN 45 MINS TO 90 HRS. OF A TPN INFUSION. IT WAS REPORTED THAT THE TPN IS CHANGED EVERY 96 HRS.,THE FACILITY IS USING MULTIPLE MANUFACTURER DISPOSABLES. THERE WAS NO REPORTED PATIENT HARM. THE EVENTS ARE OCCURRING IN MULTIPLE UNITS; HEM/ONC/BMT, BURN UNIT, NEUROSURGERY, PLASTIC SURGERY, TRAUMA UNIT, PICU, AND ENT PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438911 ↗
• MalfunctionMar 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A SITE VISIT BY A BD REPRESENTATIVES, THE STAFF REPORTED ISSUES SINCE (B)(6) 2018 WITH TPN FILTERS LEAKING AT VARIOUS TIMES WITHIN 45 MINS TO 90 HRS. OF A TPN INFUSION. IT WAS REPORTED THAT THE TPN IS CHANGED EVERY 96 HRS.,THE FACILITY IS USING MULTIPLE MANUFACTURER DISPOSABLES. THERE WAS NO REPORTED PATIENT HARM. THE EVENTS ARE OCCURRING IN MULTIPLE UNITS; HEM/ONC/BMT, BURN UNIT, NEUROSURGERY, PLASTIC SURGERY, TRAUMA UNIT, PICU, AND ENT PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438867 ↗
• MalfunctionMar 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A SITE VISIT BY A BD REPRESENTATIVES, THE STAFF REPORTED ISSUES SINCE (B)(6) 2018 WITH TPN FILTERS LEAKING AT VARIOUS TIMES WITHIN 45 MINS TO 90 HRS. OF A TPN INFUSION. IT WAS REPORTED THAT THE TPN IS CHANGED EVERY 96 HRS., THE FACILITY IS USING MULTIPLE MANUFACTURER DISPOSABLES. THERE WAS NO REPORTED PATIENT HARM. THE EVENTS ARE OCCURRING IN MULTIPLE UNITS; HEM/ONC/BMT, BURN UNIT, NEUROSURGERY, PLASTIC SURGERY, TRAUMA UNIT, PICU, AND ENT PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438811 ↗
• MalfunctionMar 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A SITE VISIT BY A BD REPRESENTATIVES, THE STAFF REPORTED ISSUES SINCE (B)(6) 2018 WITH TPN FILTERS LEAKING AT VARIOUS TIMES WITHIN 45 MINS TO 90 HRS. OF A TPN INFUSION. IT WAS REPORTED THAT THE TPN IS CHANGED EVERY 96 HRS.,THE FACILITY IS USING MULTIPLE MANUFACTURER DISPOSABLES. THERE WAS NO REPORTED PATIENT HARM. THE EVENTS ARE OCCURRING IN MULTIPLE UNITS; HEM/ONC/BMT, BURN UNIT, NEUROSURGERY, PLASTIC SURGERY, TRAUMA UNIT, PICU, AND ENT PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438783 ↗
• MalfunctionJan 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK AT THE FILTER WHEN INFUSING TPN AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT THE FILTER LEAKS STARTED IN (B)(6) 2018. THE CUSTOMER STATED THAT "THERE WAS A PRODUCT BACKORDER OF THIS PRODUCT AT THE BEGINNING OF (B)(6), AND NOT SURE IF THIS HAS ANYTHING TO DO WITH THE ISSUE." THE EVENT OCCURRED AT CHILDREN'S HOSPITAL. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR CUSTOMER DID NOT INDICATE ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224817 ↗
• MalfunctionJan 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK AT THE FILTER WHEN INFUSING TPN AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT THE FILTER LEAKS STARTED IN (B)(6) 2018. THE CUSTOMER STATED THAT "THERE WAS A PRODUCT BACKORDER OF THIS PRODUCT AT THE BEGINNING OF AUGUST, AND NOT SURE IF THIS HAS ANYTHING TO DO WITH THE ISSUE." THE EVENT OCCURRED AT CHILDREN'S HOSPITAL. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR CUSTOMER DID NOT INDICATE ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224678 ↗
• MalfunctionJan 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK AT THE FILTER WHEN INFUSING TPN AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT THE FILTER LEAKS STARTED IN (B)(6) 2018. THE CUSTOMER STATED THAT "THERE WAS A PRODUCT BACK-ORDER OF THIS PRODUCT AT THE BEGINNING OF (B)(6), AND NOT SURE IF THIS HAS ANYTHING TO DO WITH THE ISSUE". THE EVENT OCCURRED AT (B)(6) HOSPITAL. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR CUSTOMER DID NOT INDICATE ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224674 ↗
• MalfunctionJan 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK AT THE FILTER WHEN INFUSING TPN AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT THE FILTER LEAKS STARTED IN (B)(6) 2018. THE CUSTOMER STATED THAT "THERE WAS A PRODUCT BACK-ORDER OF THIS PRODUCT AT THE BEGINNING OF (B)(6), AND NOT SURE IF THIS HAS ANYTHING TO DO WITH THE ISSUE". THE EVENT OCCURRED AT (B)(6) HOSPITAL. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR CUSTOMER DID NOT INDICATE ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224651 ↗
• MalfunctionJan 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK AT THE FILTER WHEN INFUSING TPN AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT THE FILTER LEAKS STARTED IN (B)(6) 2018. THE CUSTOMER STATED THAT "THERE WAS A PRODUCT BACK-ORDER OF THIS PRODUCT AT THE BEGINNING OF (B)(6), AND NOT SURE IF THIS HAS ANYTHING TO DO WITH THE ISSUE". THE EVENT OCCURRED AT (B)(6) HOSPITAL. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR CUSTOMER DID NOT INDICATE ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224613 ↗
• MalfunctionJan 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK AT THE FILTER WHEN INFUSING TPN AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT THE FILTER LEAKS STARTED IN (B)(6) 2018. THE CUSTOMER STATED THAT "THERE WAS A PRODUCT BACKORDER OF THIS PRODUCT AT THE BEGINNING OF (B)(6), AND NOT SURE IF THIS HAS ANYTHING TO DO WITH THE ISSUE." THE EVENT OCCURRED AT (B)(6) HOSPITAL. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR CUSTOMER DID NOT INDICATE ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224611 ↗
• MalfunctionJan 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK AT THE FILTER WHEN INFUSING TPN AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT THE FILTER LEAKS STARTED IN (B)(6) 2018. THE CUSTOMER STATED THAT "THERE WAS A PRODUCT BACK-ORDER OF THIS PRODUCT AT THE BEGINNING OF (B)(6), AND NOT SURE IF THIS HAS ANYTHING TO DO WITH THE ISSUE". THE EVENT OCCURRED AT (B)(6) HOSPITAL. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS OR CUSTOMER DID NOT INDICATE ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224610 ↗