Alaris, SmartSite 2429-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10885403228018), received between Sep 24, 2018 and May 11, 2022 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 reports).

1 FDA recall record name this device's identifier.

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. May 6, 2019Class ITerminated

   An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

   Z-1770-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2022Material Separation; Air/Gas in Device; Material Separation; Air/Gas in Device

  IT WAS REPORTED WHILE USING BD ALARIS GEM 20DP V/NV CKV 3SS THE PUMP ALARMED FOR AIR IN THE LINE AND THEN SEPARATED BETWEEN THE PUMP AND SAFETY CLAMP. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE ALARIS PUMP ALARMED FOR "AIR IN LINE ON 3 OCCASIONS AND ON THE THIRD OCCASION, THE TUBING BROKE AT THE JUNCTION OF THE PUMP SEGMENT AND SAFETY CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366009 ↗
• InjuryMar 13, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING A LEVOPHED INFUSION THAT THE PUMP ALARMED "OCCLUSION". THE NURSE DISCOVERED THAT THE SILICONE SEGMENT WAS OCCLUDED, SEALING THE SIDES OF THE TUBING TOGETHER WHICH INHIBITED THE CORRECT FLOW OF MEDICATION TO THE PATIENT. THE PATIENT¿S BLOOD PRESSURE DROPPED AND THE LEVOPHED DRIP WAS INCREASED TO SUPPORT THE PATIENT'S BLOOD PRESSURE. THERE WAS NO PERMANENT HARM.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 9831810 ↗
• InjuryMar 13, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING A LEVOPHED INFUSION THAT THE PUMP ALARMED "OCCLUSION". THE NURSE DISCOVERED THAT THE SILICONE SEGMENT WAS OCCLUDED, SEALING THE SIDES OF THE TUBING TOGETHER WHICH INHIBITED THE CORRECT FLOW OF MEDICATION TO THE PATIENT. THE PATIENT¿S BLOOD PRESSURE DROPPED AND THE LEVOPHED DRIP WAS INCREASED TO SUPPORT THE PATIENT'S BLOOD PRESSURE. THERE WAS NO PERMANENT HARM.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 9831763 ↗
• MalfunctionJan 16, 2020Failure to Disconnect; Appropriate Device Problem Term/Code Not Available; Failure to Disconnect; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CODE BLUE THE TUBING WOULD NOT UNCLAMP IN THE (LVP) CHANNEL. THE PUMP ALARMED OCCLUSION, THE TUBING WAS CHANGED AND THE PUMP WORKED IMMEDIATELY. THIS EVENT OCCURRED AT THE PATIENT'S BEDSIDE, THE MEDICATION/FLUID IN THE TUBING IS UNKNOWN AND CAUSED A DELAY IN TREATMENT SINCE IV TUBING HAD TO BE CHANGED.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9597664 ↗
• MalfunctionDec 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AND INFUSION IN THE ONCOLOGY DEPARTMENT, THE PRIMARY IV TUBING SET LEAKED STEM CELLS AT THE HUB NEAREST THE PATIENT. THE PATIENT LOST 1ML OF STEM CELLS. THE TUBING SET WAS REPLACED AND THE INFUSION RESTARTED WITH NO FURTHER INCIDENTS. IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT. ALTHOUGH REQUESTED, THERE HAS BEEN NO RESPONSE TO PATIENT IMPACT OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9490326 ↗
• MalfunctionDec 9, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE FLUIDS APPEARED TO BE DRIPPING FASTER THAN THE PROGRAMMED RATE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9438360 ↗
• MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING LEAKED BELOW THE SAFETY CLAMP. DURING A PATIENT'S INFUSION, IT WAS NOTICED THAT THE IV FLUIDS WERE DRIPPING ON THE FLOOR FROM A HOLE IN THE TUBING LOCATED RIGHT BENEATH THE DOOR OF THE PUMP. ALTHOUGH REQUESTED, THERE IS NO FURTHER PATIENT OR EVENT INFORMATION AVAILABLE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9284609 ↗
• MalfunctionAug 5, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT IN THE NEONATAL ICU, THE NURSE PRIMED THE IV TUBING, PLACED IT IN THE PUMP MODULE AND IT ALARMED AIR IN LINE. THE NURSE ATTEMPTED TO REMOVE THE AIR BY FLICKING THE TUBING. THE TUBING SEPARATED AT THE UPPER FITMENT OF THE PUMPING SEGMENT AND LEAKED AN UNSPECIFIED FLUID. THE CUSTOMER STATES THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8860978 ↗
• MalfunctionAug 5, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT WHO WAS TRANSFERRED TO THEIR FACILITY WITH A 0.9% SODIUM CHLORIDE 1000ML INFUSION, HAD A BALLOONED PUMPING SEGMENT AT THE UPPER FITMENT. THE CUSTOMER STATES THAT THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8860800 ↗
• MalfunctionJul 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE RN OBSERVED THAT THE TUBING SET WAS LEAKING AT THE SITE OF THE BLUE SAFETY CLAMP DURING AN IRON INFUSION ON AN ADULT PATIENT. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8820408 ↗
• MalfunctionJun 20, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT A BALLOON DEVELOPED IN THE SILICONE SEGMENT.

  Patient problems: No Information

  MAUDE report 8718960 ↗
• MalfunctionMay 29, 2019Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging; Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE TUBING SET HAD A HOLE IN IT AND LEAKED.

  Patient problems: No Information

  MAUDE report 8649758 ↗
• MalfunctionMay 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A QUESTION ABOUT A TUBING LEAK DURING AN INFUSION OF TPN ON A PUMP IN THE NICU. THE TPN THAT WAS INFUSING WAS FOUND ON THE BED. THERE WAS NO PATIENT HARM. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS GIVEN.

  Patient problems: No Information

  MAUDE report 8582833 ↗
• MalfunctionMar 26, 2019Reflux within Device; Reflux within Device

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "PATIENT HAD A SECONDARY MEDICATION ATTACHED TO PRIMARY TUBING AND A PUMP. THE PATIENT DID NOT RECEIVE THE MEDICATION AND IT IS EITHER AN ISSUE WITH THE MEDICATION TUBING OR THE INFUSION PUMP. THE MEDICATION IN THE SECONDARY BAG FILLED UP WITH MORE FLUID SO UNSURE WHAT DOSE OF MEDICATION THE PATIENT RECEIVED. ALARIS PUMP FROM CARDINAL HEALTH, MODEL# 8015, LOT# 2013-8, SERIAL# (B)(4), CATALOG# 10019205". THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453140 ↗
• MalfunctionMar 25, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN INFUSION USING A PUMP, THE SILICONE SEGMENT BALLOONED. IT WAS UNKNOWN IF THERE WERE ANY PUSHES GIVEN BEFORE, DURING OR AFTER THE INFUSION. THERE WAS NO PATIENT HARM. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448720 ↗
• MalfunctionMar 4, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE SET WAS RECEIVED UNEXPECTEDLY IN A BAG WITH OTHER RETURNS FROM THE SAME CUSTOMER. THE OTHER SETS HAVE BEEN REPORTED TO LEAK, POTENTIALLY FROM A CRACK OR FLUSH. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8388429 ↗
• MalfunctionFeb 22, 2019Crack; Crack

  RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, ¿NURSE FOUND SMARTSITE IV TUBING TO BE CRACKED AT SITE WITH TUBING CONNECTED TO PATIENT." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2018 WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362995 ↗
• MalfunctionFeb 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "PATIENT RECEIVING 300 MLS ALBUMIN OVER 1.5 HOURS INFUSION TIME. NO COMPLICATIONS NOTED DURING ALBUMIN INFUSION. HOWEVER, NOTICED LEAKING OF SMARTSITE TUBING FROM BASE OF IV PUMP WHEN 50 MLS NS FLUSH WAS ALMOST COMPLETE. APPROXIMATELY 2-3 MLS OF FLUID NOTED BELOW PUMP. INFUSION STOPPED AND SUPPLIES WITH SAME LOT NUMBER REMOVED FROM OMNICELL." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2018 WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358088 ↗
• MalfunctionFeb 20, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "NURSE ENTERED PATIENT'S ROOM 15 MINUTES AFTER INITIATION OF REMICADE INFUSION TO TITRATE RATE AS ORDERED. PATIENT REPORTED FLUID LEAKING FROM BOTTOM OF THE IV PUMP. UPON FURTHER INSPECTION, NURSE FOUND SMALL BREAK IN THE "PUMP SEGMENT" TUBING OF THE SMARTSITE INFUSION SET, RESULTING IN SLOW LEAK OF MEDICATION FROM INFUSION SET. INFUSION IMMEDIATELY STOPPED AND DISCONNECTED FROM PATIENT. REMICADE BAG WAS REPLACED AND INFUSION RESUMED WITH NEW SMARTSITE INFUSION SET. NO FURTHER COMPLICATIONS NOTED". AN INCOMPLETE DATE OF EVENT OF (B)(6) 2018 WAS PROVIDED, AND THIS OCCURRED IN A CRITICAL CARE UNIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8356494 ↗
• MalfunctionFeb 20, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE SET WAS RECEIVED UNEXPECTEDLY WITH A REPORT THAT IT LEAKED, POTENTIALLY FROM A CRACK OR FLUSH. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8356401 ↗
• MalfunctionFeb 14, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE SET WAS RECEIVED UNEXPECTEDLY WITH A REPORT THAT IT LEAKED, POTENTIALLY FROM A CRACK OR FLUSH. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341713 ↗
• MalfunctionFeb 5, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING AN INFUSION OF D5 WITH SODIUM BICARBONATE AT 125ML/HR, THE TUBING WAS SPLIT AND LEAKING AT THE UPPER FITMENT. ALTHOUGH REQUESTED, THERE ARE NO FURTHER DETAILS THAT HAVE BEEN PROVIDED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8306477 ↗
• MalfunctionJan 30, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT AT THE END OF A METHOTREXATE SECONDARY INFUSION, A SMALL HOLE AND LEAK WAS OBSERVED NEAR THE UPPER FITMENT AT THE TOP OF THE PUMP SEGMENT. AT THE TIME THE LEAK WAS DISCOVERED, THE PUMP HAD STARTED TO ALARM FOR AIL AND THE NURSE OBSERVED YELLOW METHOTREXATE DRIPPING OFF THE PUMP. THE PUMP WAS TURNED OFF, THE TUBING CLAMPED AND DISCONNECTED FROM THE PATIENT¿S PICC LINE. THE PHARMACIST ESTIMATED THAT THE PATIENT RECEIVED ALL BUT 8ML OF THE MEDICATION. THE CHEMO MEDICATION DID NOT DRIP ON THE PATIENT, AND NO ADVERSE EFFECTS TO THE PATIENT OR CLINICIANS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289477 ↗
• MalfunctionJan 30, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT DURING A FENTANYL INFUSION IN THE EMERGENCY DEPARTMENT, A SMALL HOLE AND LEAK WAS OBSERVED NEAR THE UPPER FITMENT AT THE TOP OF THE PUMP SEGMENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289295 ↗
• MalfunctionJan 18, 2019Crack

  NURSE FOUND SMARTSITE IV TUBING TO BE CRACKED AT SITE WITH TUBING CONNECTED TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8260124 ↗