Alaris, SmartSite 11607704Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10885403228001), received between Nov 22, 2017 and Feb 1, 2023 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT THE BD ALARIS INFUSION SET IS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV PUMP TUBING FOUND IN SUPPLY ROOM STOCK WITH A DISCOLORED CHAMBER. THE CHAMBER IS BROWN IN COLOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280837 ↗
• MalfunctionNov 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE BD ALARIS INFUSION SET EXPERIENCED TUBING EXPANSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV PUMP WAS ALARMING, SAYING THE CLAMP WAS NOT CLOSED AFTER TRYING TO PUSH IV ZOFRAN THROUGH THE PATIENT'S PRIMARY IV TUBING AND MEETING SOME RESISTANCE. OPENED CLAMP TO DISCOVER THE PRIMARY TUBING HAD A LARGE LIQUID BUBBLE M THE SECTION OF THE TUBING THAT CLAPS INTO THE CHANNEL OF THE IV PUMP. TUBING WAS CHANGED AT THIS TIME WITHOUT ANY FURTHER PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738626 ↗
• MalfunctionOct 5, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE AS LVP 20D 2SS CV EXPERIENCED TUBING EXPANSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBING IN THE PUMP WAS SAYING THAT THE CLAMP WAS NOT CLOSED AND MET SOME RESISTANCE, ONCE SHE OPENED THE CLAMP THERE WAS A BUBBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579506 ↗
• MalfunctionJun 16, 2020Crack; Crack

  THE CUSTOMER RECEIVED THE IV TUBING SET FROM STAFF WITH NO INFORMATION, AND REPORTED THAT THERE WAS AN UNSPECIFIED IV TUBING SET ISSUE. WHEN THE PRODUCT WAS SENT TO BD FOR INVESTIGATION AND RECEIVED, IT WAS THEN NOTED THAT THE TUBING SET HAD A TEAR AND WAS LABELED "CRACKED." THE TUBING SET ALSO WAS LABELED "AMIO" WHICH IS MOST LIKELY AN AMIODARONE INFUSION. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO A PATIENT FROM ANY EVENT INVOLVING THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 10158278 ↗
• MalfunctionJun 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE IV TUBING SET SEPARATED AT THE SLIDE CLAMP. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10151499 ↗
• InjuryMar 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THERE WERE AIR-IN-LINE ALARMS. THE NURSE TRIED THREE DIFFERENT PCUS AND FIVE DIFFERENT LVPS, AS WELL AS TWO DIFFERENT TUBING SETS. AS A RESULT OF THE EVENT, THE PATIENT'S HEART RATE REMAINED INCREASED, REQUIRING A REPEAT BOLUS OF CARDIZEM. THE PATIENT'S HEART RATE STARTED AT 156 BPM BUT REMAINED ELEVATED AT 142 BPM DURING THE AIR-IN-LINE ALARMS. A BOLUS DOSE OF 25 MG OF CARDIZEM WAS ADMINISTERED AND THE HEART RATE DECREASED TO 110 BPM.

  Patient problems: Tachycardia

  MAUDE report 9860849 ↗
• InjuryMar 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THERE WERE AIR-IN-LINE ALARMS. THE NURSE TRIED THREE DIFFERENT PCUS AND FIVE DIFFERENT LVPS, AS WELL AS TWO DIFFERENT TUBING SETS. AS A RESULT OF THE EVENT, THE PATIENT'S HEART RATE REMAINED INCREASED, REQUIRING A REPEAT BOLUS OF CARDIZEM. THE PATIENT'S HEART RATE STARTED AT 156 BPM BUT REMAINED ELEVATED AT 142 BPM DURING THE AIR-IN-LINE ALARMS. A BOLUS DOSE OF 25 MG OF CARDIZEM WAS ADMINISTERED AND THE HEART RATE DECREASED TO 110 BPM.

  Patient problems: Tachycardia

  MAUDE report 9860781 ↗
• MalfunctionFeb 4, 2020Break; Break

  IT WAS REPORTED THAT IV TUBING SPIKE BROKE OFF IN IV BAG WHEN RN ATTEMPTED TO SPIKE THE IV BAG. THERE WAS NO PATIENT HARM. ALTHOUGH REQUESTED, PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9668126 ↗
• MalfunctionDec 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE TUBING CAME APART WHILE HANGING A NEW BAG OF PROPOFOL, PRIOR TO BEING PLACED IN THE DEVICE AT THE TIME OF EVENT. CRITICAL CARE SERVICES. THERE WAS NO PATIENT INVOLVEMENT. THE TUBING WAS IN USE FOR (2) DAYS. (RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM FDA WHICH STATES, ¿WHILE HANGING NEW BAG OF PROPOFOL INFUSION AND TUBING IN ALANS PUMP, TUBING CAME APART AT CONNECTION SITE. NURSE REPRIMED A NEW SET OF TUBING, PLACED IN IV PUMP AND INFUSING WITHOUT DIFFICULTY".)

  Patient problems: No Information; No Patient Involvement

  MAUDE report 9513181 ↗
• MalfunctionDec 4, 2019Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT THE PATIENT WAS HOOKED UP TO NORMAL SALINE (NS) TO ANOTHER MANUFACTURE PORT. THE TUBING WAS BROKEN AT THE Y-SITE AND THE BLOOD HAD STARTED TO FLOW OUT OF THE REMAINING TUBING THAT WAS STILL ATTACHED TO THE PATIENT. THE PATIENT WAS ATTACHED TO ONE USED 100ML BAXTER GALAXY SINGLE DOSE CONTAINER, AND CEFEPIME INJECTION 2G. ALTHOUGH REQUESTED, THERE HAS BEEN NO IMPACT TO PATIENT RESPONSE OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.

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

  MAUDE report 9410031 ↗
• MalfunctionNov 22, 2019Backflow; Reflux within Device; Backflow; Reflux within Device

  IT WAS REPORTED THAT AFTER HOOKING UP THE SECONDARY INFUSION OF CARBOPLATIN AND OPENING THE CLAMP IT FREE-FLOWED DOWN INTO THE PRIMARY BAG WHICH WAS HUNG LOWER THAN THE SECONDARY. THE PUMP WAS NOT STARTED YET. THE PATIENT DID NOT RECEIVE ANY MEDICATION. THEY CHANGED ALL THE TUBING AND IT HAPPENED AGAIN SO THEY CHANGED THE PUMP AND IT FLOWED NORMALLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9366508 ↗
• MalfunctionNov 13, 2019Stretched; Material Deformation; Stretched; Material Deformation

  IT WAS REPORTED THAT THE SILICONE SECTION OF A (3) PORT IV ADMINISTRATION SET "BALLOONED", WHILE IN THE ALARIS INFUSION PUMP CHANNEL. IT WAS FURTHER CONFIRMED THAT THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9319501 ↗
• MalfunctionOct 17, 2019No Flow

  RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, ¿SECONDARY MEDICATION WAS HUNG BUT WHEN THE RN STARTED THE PUMP MEDICATION WAS NOT COMING OUT OF THE END OF THE LINE - DRIPS IN DRIP CHAMBER" IT WAS REPORTED THAT KEPPRA (1000MG/100ML) WAS PROGRAMMED AT A RATE OF 400ML/HR. HOWEVER WHEN THE DEVICE WAS PROGRAMMED TO INFUSE THE MEDICATION WOULD NOT FLOW. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9205209 ↗
• MalfunctionOct 14, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE IV TUBING SET BROKE AND SPILLED ITS CONTENTS WHEN CHEMOTHERAPY WAS BEING HUNG VIA THE PRIMARY TUBING ON THE PUMP MODULE ATTACHED TO AN IV POLE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Information

  MAUDE report 9188386 ↗
• MalfunctionAug 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER SPIKING THE PROPOFOL BOTTLE AND INSERTING THE TUBING SET INTO THE PUMP, IT WAS NOTED THAT THE TUBING SET WAS LEAKING. UPON OBSERVATION, IT WAS NOTED THAT THE LEAK WAS FOUND TO BE AT THE UPPER FITMENT. THE CUSTOMER LATER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8913678 ↗
• MalfunctionAug 14, 2019Material Deformation; Material Deformation

  IT WAS REPORTED DURING A POTASSIUM 30MEQ/NORMAL SALINE 100ML AT A RATE OF 100ML/HOUR THAT THE TUBING SET DEVELOPED A BALLOON IN THE SILICONE SEGMENT CAUSING THE IV INFUSION TO NOT FLOW PROPERLY TO THE PATIENT. THE CUSTOMER VALIDATED THAT THERE WERE NO IV PUSHES ADMINISTERED PRIOR TO THE BALLOON DEVELOPING IN THE SILICONE SEGMENT. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT. RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, ¿IV PUMP TUBING DEVELOPED AN OUTPOUCHING (LOOKS LIKE A LARGE BUBBLE IN THE TUBING) CAUSING THE IV FLUIDS TO NOT FLOW PROPERLY TO THE PATIENT. PATIENT SUFFERED NO INJURY." THE MEDWATCH ALSO STATED THAT THE EVENT OCCURRED IN THE CRITICAL CARE DEPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8895091 ↗
• InjuryAug 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, ¿PATIENT'S GOWN WAS WET. FOUND THAT THE Y SITE OF THE IV TUBING WAS LEAKING FROM THE LINE ATTACHED TO THE INSULIN DRIP." IT WAS REPORTED THAT INSULIN (100ML) WAS PROGRAMED AT A RATE OF 20ML/HR AT 0445, AND THEN TITRATED TO A RATE OF 32ML/HR AT 0801. THE NURSE STATED THAT DUE TO THE TUBING LEAK, THE PATIENT REQUIRED MORE FREQUENT BLOOD GLUCOSE LABS DRAWN WITH RESULTS OF 325MG/DL AND 249MG/DL. ALTHOUGH 'REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE' WAS SELECTED ON THE MEDWATCH, THE CUSTOMER VERIFIED THERE WAS NO MEDICAL INTERVENTION PROVIDED OR PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875740 ↗
• MalfunctionAug 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, ¿IV FLUIDS DRIPPING OUT OF Y SITE PORT. UNKNOWN IF THE PATIENT WAS RECEIVING FLUID. IV TUBING LOT # 19055609." IT WAS REPORTED THAT DEXTROSE D50 WAS PROGRAMMED AT A RATE 50ML/HR. VIA CENTRAL LINE, THE USER STATED THAT THE TUBING WAS CORRECTLY INSERTED INTO THE DEVICE HOWEVER WHEN THE NURSE REMOVED THE CUROS CAP A LEAK WAS NOTED AT THE SMARTSITE VALVE PROXIMAL TO THE DRIP CHAMBER. IT WAS LATER REPORTED THAT NURSING PRACTICE WAS TO PLACE CUROS CAPS ON ALL SMARTSITE VALVES IF CONNECTED TO A CENTRAL LINE. THERE WAS NO REPORT FROM THE CUSTOMER OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8859856 ↗
• MalfunctionJul 16, 2019Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  IT WAS REPORTED THE DEVICE ALARMED FOR OCCLUSION ALARMS DURING AN INFUSION OF D51/2NS 20 MEQ KCL PROGRAMMED AT A RATE OF 80 ML/HR. UPON CLOSER OBSERVATION THE USER NOTICED THAT THE TUBING WAS OCCLUDED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT, PATIENT OR DEVICE INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795012 ↗
• MalfunctionJul 9, 2019Excess Flow or Over-Infusion; Use of Device Problem; Insufficient Device Problem Information; Application Program Problem: Medication Error; Excess Flow or Over-Infusion; Use of Device Problem; Insufficient Device Problem Information; Application Program Problem: Medication Error

  IT WAS REPORTED THAT PROPOFOL WAS INFUSING AT AN UNSPECIFIED RATE HOWEVER 45 MINS LATER THE RN NOTICED THAT HALF THE BOTTLE OF PROPOFOL WAS ADMINISTERED. THE RN TURNED THE DEVICE OFF AND RESTARTED WITH NOT FURTHER ISSUES. THE EVENT OCCURRED IN THE MICU. IT WAS LATER REPORTED "THIS TURNED OUT NOT TO BE AN ISSUE AT ALL AFTER INVESTIGATING, AS IT WAS DETERMINED TO BE A MISCALCULATION".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8770545 ↗
• MalfunctionJun 3, 2019Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE UNIT MANAGER WAS ANSWERING A CALL LIGHT AND WAS ASSISTING THE PATIENT TO THE BATHROOM WHEN THE ALARIS LVP DETACHED FROM THE PCU AND FELL CAUSING THE TUBING SET TO SEPARATE DURING A MAGNESIUM/0.9% SODIUM CHLORIDE INFUSION.

  Patient problems: No Information

  MAUDE report 8664966 ↗
• MalfunctionMay 13, 2019Backflow; Backflow

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "EARLY MARCH, A NURSE WAS ADMINISTERING A SECONDARY MEDICATION WHEN SHE NOTICED THAT THE MEDICATION WAS REFLUXING BACK INTO THE PRIMARY BAG - PAST THE INFUSION LINE BACK CHECK VALVE. FIVE DAYS LATER, THIS DEFECT WAS REPORTED AGAIN BY A SECOND INDIVIDUAL." THE ORIGINAL INTENDED PROCEDURE WAS FOR MEDICATION ADMINISTRATION. AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. THE EVENT OCCURRED IN A PATIENT ROOM.

  Patient problems: No Information

  MAUDE report 8606426 ↗
• MalfunctionMay 7, 2019Backflow; Backflow

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "EARLY (B)(6), A NURSE WAS ADMINISTERING A SECONDARY MEDICATION WHEN SHE NOTICED THAT THE MEDICATION WAS REFLUXING BACK INTO THE PRIMARY BAG - PAST THE INFUSION LINE BACK CHECK VALVE. FIVE DAYS LATER, THIS DEFECT WAS REPORTED AGAIN BY A SECOND INDIVIDUAL." THE ORIGINAL INTENDED PROCEDURE WAS FOR MEDICATION ADMINISTRATION. AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. THE EVENT OCCURRED IN A PATIENT ROOM.

  Patient problems: No Information

  MAUDE report 8588169 ↗
• MalfunctionApr 9, 2019Complete Blockage; Material Twisted/Bent

  BD ALARIS PUMP INFUSION SET REF# 11607704. FOUND TO HAVE KINK/OCCLUSION DIRECTLY BELOW THE DRIP CHAMBER. THIS IS NEW TUBING FROM THE PACKAGE THAT DOES NOT WORK. LOT# 19025115.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495518 ↗
• MalfunctionMar 11, 2019Material Deformation; Material Deformation

  CUSTOMER REPORTED THEY NOTICED A BULGE IN THE SILICONE SECTION OF THE TUBING. THERE WAS NO REPORT OF HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8410102 ↗