Alaris, SmartSite, Texium 10013361TRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10885403223204), received between May 26, 2017 and Apr 6, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 reports).

3 FDA recall records name this device's identifier, 2 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. May 12, 2025Class IIOpen, Classified

   Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

   Z-1970-2025 · Root cause: Process control · Recall details · FDA record ↗

3. 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT A LEAKING PRIMARY SET ON A LEUCOVORIN INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794104 ↗
• MalfunctionJan 6, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE TEXIUM TUBING LEAKING AT THE TEXIUM TIP WITH CYCLOPHOSPHAMIDE ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977190 ↗
• MalfunctionNov 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS RN STARTED THE PATIENT'S ETOPOSIDE INFUSION. APPROXIMATELY 1-2 MINUTES INTO THE INFUSION, THE PATIENT STATED THAT THE TUBING WAS LEAKING. THIS RN IMMEDIATELY STOPPED THE INFUSION AND ASSESSED THE TUBING. THE TUBING WAS TIGHTENED ON COMPLETELY AND MEDICATION WAS LEAKING AROUND THE TEXIUM. THIS RN CALLED OVER PHARMACIST AND THE MEDICATION WAS TAKEN BACK TO THE PHARMACY FOR THE TUBING TO BE REPLACED. IT WAS DETERMINED THAT SALINE WAS STILL IN THE LINE AND IT WAS NOT CHEMO THAT LEAKED ONTO THE PATIENT. THE ETOPOSIDE INFUSION WAS RESTARTED WITH NEW TUBING AND THERE WERE NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467376 ↗
• MalfunctionNov 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS RN STARTED THE PATIENT'S ETOPOSIDE INFUSION. APPROXIMATELY 1-2 MINUTES INTO THE INFUSION, THE PATIENT STATED THAT THE TUBING WAS LEAKING. THIS RN IMMEDIATELY STOPPED THE INFUSION AND ASSESSED THE TUBING. THE TUBING WAS TIGHTENED ON COMPLETELY AND MEDICATION WAS LEAKING AROUND THE TEXIUM. THIS RN CALLED OVER PHARMACIST AND THE MEDICATION WAS TAKEN BACK TO THE PHARMACY FOR THE TUBING TO BE REPLACED. IT WAS DETERMINED THAT SALINE WAS STILL IN THE LINE AND IT WAS NOT CHEMO THAT LEAKED ONTO THE PATIENT. THE ETOPOSIDE INFUSION WAS RESTARTED WITH NEW TUBING AND THERE WERE NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467201 ↗
• MalfunctionDec 2, 2024Leak/Splash; Leak/Splash

  MATERIAL #: 10013361T BATCH#: UNKNOWN IT WAS REPORTED BY CUSTOMER THAT WE HAD ANOTHER ISSUE WITH A LEAK BUT THIS TIME FROM A DIFFERENT SITE ON THE LINE WITH AN OXALIPLATIN AT ZUCKERBERG. CAN SOMEBODY PLEASE COME IN THIS WEEK TO ASSESS, WE NEED TO UNDERSTAND WHY WE ARE EXPERIENCING THESE LEAKS SUDDENLY. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. WE HAD ANOTHER ISSUE WITH A LEAK BUT THIS TIME FROM A DIFFERENT SITE ON THE LINE WITH AN OXALIPLATIN AT ZUCKERBERG. CAN SOMEBODY PLEASE COME IN THIS WEEK TO ASSESS, WE NEED TO UNDERSTAND WHY WE ARE EXPERIENCING THESE LEAKS SUDDENLY.

  Patient problems: Insufficient Information

  MAUDE report 20825280 ↗
• MalfunctionNov 26, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 10013361T BATCH#: 24075224. IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER STATED THAT THEY WE JUST HAD ANOTHER LEAK. VERBATIM: CUSTOMER STATED THAT THEY WE JUST HAD ANOTHER LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787073 ↗
• MalfunctionNov 18, 2024Leak/Splash; Leak/Splash

  MATERIAL# 10013361T BATCH# 24075224. IT WAS REPORTED BY CUSTOMER THAT WE¿VE HAD ANOTHER LEAK WITH DOXIL AT THE POINT WHERE THE TEXIUM MEETS THE TUBING AND IT¿S SUPPOSED TO BE BONDED. THE PATIENT HAD TO DISCARD THEIR JACKET BECAUSE IT LEAKED ON THEM. WE KEPT THE CONTENTS OF THE LEAK FOR YOU TO INSPECT. WE NEED TO ADDRESS THESE INCIDENCES AS THEY ARE AFFECTING PATIENT CARE. VERBATIM: WE¿VE HAD ANOTHER LEAK WITH DOXIL AT THE POINT WHERE THE TEXIUM MEETS THE TUBING AND IT¿S SUPPOSED TO BE BONDED. THE PATIENT HAD TO DISCARD THEIR JACKET BECAUSE IT LEAKED ON THEM. WE KEPT THE CONTENTS OF THE LEAK FOR YOU TO INSPECT. WE NEED TO ADDRESS THESE INCIDENCES AS THEY ARE AFFECTING PATIENT CARE. LOT (10)24075224 REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20709907 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE MENTIONED ITEM WERE INVOLVED IN A SPILL TODAY, ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664987 ↗
• MalfunctionOct 27, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20540990 ↗
• MalfunctionSep 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM 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 SETS BREAKING AND SUBSEQUENTIALLY RESULTING IN A CHEMO SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182340 ↗
• MalfunctionJul 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET THERE WAS A BLOCKAGE. THERE WAS NO REPORT OF PATIENT IMPACT.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY STATED THAT THEIR PRACTICE FOR ADMINISTRATION OF AN IVP VIA THIS TEXIUM SET HAS NOT CHANGED DURING THIS TRIAL WITH OPTIMA BEING USED AT THE DISTAL ACCESS PORT OF THE SET FOR AN IVP. PRIOR TO OPTIMA THEY USED A TEXIUM BONDED IVP SYRINGE FOR ADMINISTRATION. XXX REACHED OUT TO THE PRIMARY RN FOR THE EXACT DETAILS. THIS IS WHAT THEY STATED, ¿I NOTICED THE DRIP RATE HAD SLOWED DOWN AND WHEN I STARTED PUSHING THE DRUG, THE DRIP HAD COMPLETELY STOPPED AND THE DRUG WOULD STARTING BACK UP THE Y-SITE TOWARDS THE PUMP. I DIDN¿T DO THE PINCH LINE METHOD FOR THIS BECAUSE OF HOW SLOW THE CARRIER FLUID WAS FLOWING. ONCE THE LINE WAS SLIGHTLY CLEAR, I WOULD THEN PINCH THE LINE AND CHECK FOR BLOOD RETURN. WITH THE SECOND SYRINGE, I NOTICED THE PRESSURE TO PUSH THE DRUG WOULD INCREASE WHEN THE SYRINGE WAS CLOSE TO BEING HALFWAY EMPTY (LIKE MAYBE 10MLS LEFT). AT ONE POINT, I PUSHED THE DRUG A LITTLE TOO HARD AND THE PATIENT REPORTED FEELING PRESSURE AT HIS PORT SITE. THE PATIENT¿S PORT SITE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322391 ↗
• MalfunctionNov 4, 2019Stretched; Material Deformation; Stretched; Material Deformation

  IT WAS REPORTED THAT THE TUBING SET DEVELOPED A "BUBBLE" IN THE SILICONE SEGMENT WHILE ATTACHED TO A COMBINED CHEMOTHERAPY INFUSION BAG OF DOXORUBICIN (ADRIAMUCIN) 16.4M, ETOPOSIDE (TOPOSAR) 82MG/SODIUM CHLORIDE 0.9%, 1000ML, TO INFUSE AT A RATE OF 44.3ML/HOUR FOR A DURATION OF (24) HOURS, WITH A TOTAL VTBI OF 1062.3ML. THE CUSTOMER FURTHER STATED THAT THERE WERE NO IV PUSH MEDICATIONS ADMINISTERED PRIOR TO THE "BALLOON" DEVELOPING IN THE TUBING SET. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE ADULT PATIENT FROM THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9276513 ↗
• MalfunctionOct 25, 2019Break; Break

  IT WAS REPORTED THAT DURING AN INFUSION, CYTARABINE 220 MG IV IN 100 ML WAS CIRCLE PRIMED WITH TEXIUM TUBING AND INSERTED INTO THE ALARIS PUMP AFTER ATTACHING TO PATIENT. RN ADJUSTED THE BLUE PLASTIC PIECE ABOVE THE DOOR CHANNEL, WHEN THE TUBING BROKE AND CHEMO STARTED SPILLING. RN WAS ABLE TO CONTAIN SPILL BY CLAMPING RED CLAMP ON EXTENSION TUBING (LOCATED BETWEEN PHARMACY FACILE AND CYTRARBINE BAG). DURING THIS PROCESS, CHEMO WAS SPLASHED, RN WAS FULLY GOWNED UP WITH CHEMO GOWN, DOUBLE GLOVED WITH CHEMO GLOVES, HAD M95 MASK AND GOGGLES ON, HOWEVER; A DROP OF CHEMO LANDED ON RN'S RIGHT NECK. RN CLEANED UP THE CHEMO IMMEDIATELY AND FOLLOWING CLEAN OF SPILL, WASHED NECK WITH SOAP AND WATER. CHEMO WAS RECORDED AND SCHEDULED TO START AT 11:00PM INSTEAD OF 10:00PM START TIME. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241836 ↗
• MalfunctionOct 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN INFUSION OF ETOPOSIDE 200 MG / 500 ML, THE RN CAME TO DO AN FLUSH CHEMO. THE IV TUBING TOLERATED 15ML, BUT BURST AT THE TOP OF THE CHANNEL SITE, RELEASING FLUIDS ON THE RN'S FOREHAND, CHANNEL AND HANDS. RN WAS WEARING PPE, HOWEVER; FOREHEAD WAS CONTAMINATED. CHARGE RN WAS AWARE AND WAS THE BEDSIDE WITH A SECOND NURSE AND CHEMO SPILL KIT. THE RN AFFECTED BY THE CHEMO SPILL WASHED FACE FOR 15 MINUTES. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241609 ↗
• MalfunctionJun 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VISIBLE RESIDUE OF HAZARDOUS DRUGS ON CONNECTING SURFACES UPON DISCONNECTION WHEN THEY PREPARE CHEMO IN THEIR PHARMACY 90-100% OF THE TIME EVERY DAY FOR THE PAST 5 YEARS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733080 ↗
• MalfunctionMar 29, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING WHICH WAS INFUSING ETOPOSIDE TO A PATIENT WAS NOTED TO BE CRACKED AND LEAKING BETWEEN THE FUSED TEXIUM AND TUBING. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463043 ↗
• MalfunctionDec 6, 2018Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT THE TUBING BALLOONED AND COLLAPSED IN THE PUMP AND CREATED A BLOOD RETURN FROM THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8140348 ↗
• MalfunctionOct 24, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING WHICH WAS INFUSING ETOPOSIDE TO A PATIENT WAS NOTED TO BE CRACKED AND LEAKING BETWEEN THE FUSED TEXIUM AND TUBING. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8003372 ↗
• MalfunctionAug 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A CHEMO SPILL WAS CAUSED BY A LEAK AT THE ENGAGEMENT TO THE LOWER FITMENT DURING A PATIENT'S INFUSION. THE CHEMO GOT ON THE PATIENT'S SKIN AND CLOTHES, BUT THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806099 ↗
• MalfunctionMay 26, 2017Fluid/Blood Leak

  PATIENT SEEN AT OUTPATIENT INFUSION CENTER (B)(6) TO RECEIVE BEVACIZUMAB INFUSION. RN STARTING INFUSION ON PATIENT NOTICED LEAKING FROM THE INFUSION SET WHERE THE FLEXIBLE TUBING ATTACHES TO THE ENDCAP JUST PRIOR TO THE TEXIUM CONNECTOR. RN RETURNED TO PHARMACY FOR NEW SET UP PRIOR TO BEGINNING INFUSION. INFUSION SET BD 10013361T; LOT # 16126804. ACTUAL TUBING SET WAS DISCARDED DUE TO LEAKING CONTENTS BUT LOT # NOTED. THIS IS SAME LOCATION OF DEFECT ON THE SAME INFUSION SET REPORTED BY (B)(6) REPORTED SEPARATELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6600865 ↗
• MalfunctionMay 26, 2017Device Dislodged or Dislocated

  DEFECTIVE INFUSION SET. THIS EVENT INVOLVES HOSPITALIZED INPATIENT RECEIVING CONTINUOUS INFUSION DOXORUBICIN CHEMOTHERAPY. PATIENT CALLED NURSE TO REPORT "TUBING POPPED OUT WHEN I TURNED TO THE SIDE". PATIENT QUICKLY REATTACHED TUBING AND NO EVIDENCE OF CHEMO SPILL. RN DISCONNECTED AND SAVED TUBING FOR PHARMACY TO INSPECT. THE INFUSION SET WAS BD 10013361T; LOT #15095909. THE FLEXIBLE PLASTIC TUBING HAD DISCONNECTED FROM THE CONFIRMING SEPARATION DUE TO INSUFFICIENT BONDING SOLVENT; A PROBLEM IN THE MANUFACTURING PROCESS. I ASKED IF THIS WAS LOT RELATED AND IF THERE WAS ANY RECALL OF THE PRODUCT. RESPONSE FROM BD WAS NO RECALL AND CORRECTIVE ACTION PLAN IN PLACE TO RESOLVE THE ISSUE. SECOND ISSUE WITH INFUSION SETS AT SAME CONNECTION SPOT ON DIFFERENT PATIENT PROMPTED THIS REPORTING TO FDA. WILL FILE SEPARATE REPORT FOR SECOND INCIDENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6600856 ↗