Alaris, SmartSite 2447-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403235078), received between Jan 24, 2019 and Mar 26, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 18, 2026.

Recalls naming this device

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2024Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT UNSPECIFIED BD INFUSION SET HAD FLOW PROBLEMS THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING : IT WAS REPORTED THAT THE DEVICE HAD UNKNOWN ISSUE. THIS WAS REPORTED TO BD REPRESENTATIVES DURING THEIR SITE VISIT. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT. "IV PUMP OR BURITROL HAD FLOW ISSUES. AFTER NOTICING BLOOD BACKING UP IN LINE NURSE ATTEMPTED TO FLUSH, LINE DIDN'T FLUSH. NURSE NOTICED WETNESS ALONG THE OUTSIDE OF THE LINE AND THAT FLUID WAS FLOWING BACK UP THE LINE AND OUT THE TOP PORT. NURSE PULLED A CLOT THE SIZE OF THE CATHETER OUT FROM IV SITE AFTER REMOVING IT. PUMP NEVER ALARMED THAT THERE WAS A CLOT OR ANY OTHER PROBLEMS."

  Patient problems: Insufficient Information

  MAUDE report 18980698 ↗
• MalfunctionJul 8, 2022Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD ALARIS¿ LVP BUR 60D 2SS BV WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STERILE TUBING CHANGE WAS COMPLETED FOR UVC INFUSING TPN @ 1700. @ 1745 THE PUMP WAS ALARMING AIR IN LINE. WHEN I WAS REMOVING AIR FROM THE LINE IT WAS NOTED TO BE SLIGHTLY WET. UPON FURTHER INSPECTION, THERE WAS A TINY HOLE IN THE TUBING LEAKING TPN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955878 ↗
• MalfunctionMay 10, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRYING TO PRIME IVIG (INTRAVENOUS IMMUNE GLOBULIN) AND NOTICED THAT THE MEDICATION WASN'T GOING INTO THE BALL CHAMBER IN ORDER TO PRIME. SQUEEZED IT MULTIPLE TIMES, FLIPPED IT AROUND, OPENED ALL THE CLAMPS, BUT IT WASN'T GOING INTO THE BALL CHAMBER. HAD TO REMOVE THE IVIG IN THE BURETTE SINCE IT WOULDN'T PRIME. NO HARM CAME TO THE PATIENT, BUT LUCKILY, WE WERE ABLE TO PULL THE MEDICATION OUT OF THE CHAMBER WITH THE PORT ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347485 ↗
• MalfunctionNov 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 BD ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION SETS EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLUE STOPPER/RUBBER TOP OF A GAMMAGARD S/D 50ML BOTTLE FELL INTO THE MEDICATION BOTTLE AS BOTTLE WAS BEING SPIKED WITH A BURETROL TUBING SETUP. BOTTLE WAS DUE TO BE SPIKED; PRIMED, AND THEN MEDICATION TO BE ADMINISTERED TO PATIENT. IT HAS BEEN NOTED THAT WITH PREVIOUS SETUPS; THAT SPIKING COULD CREATE A VACUUM CAUSING THE BURETROL TO COMPRESS INWARDS. THEREFORE, PRIOR TO SPIKING THIS BOTTLE; RN INSERTED A BLUNT NEEDLE WITH A SYRINGE (NO ADDITIONAL AIR INJECTED INTO BOTTLE). SYRINGE REMOVED TO DECOMPRESS AND LET AIR OUT OF BOTTLE. BLUNT NEEDLE REMOVED. WHEN SPIKING THE BOTTLE, THE BLUE STOPPER/RUBBER TOP FELL INTO GLASS BOTTLE. PROCESS WAS STOPPED AND BOTTLE PUT ASIDE. PHARMACISTS MENTIONED THIS IS THIRD TIME THIS HAS HAPPENED RECENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888305 ↗
• MalfunctionAug 18, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE GEM BURETTE V/NV 60DP PS 3SS DEHP FREE EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM GOING TO SPEAK WITH THE CAREGIVER THAT TURNED IT IN, BUT WANTED TO BRING IT TO YOUR ATTENTION. THIS WAS PLACED IN MY DOOR LAST NIGHT (7/27). THIS IS WHAT WAS FOUND WITH THEY WENT TO TAKE THE CAP OFF OF THE SPIKE STRAIGHT OUT OF THE PACKAGE. I AM GOING TO VERIFY THAT SHE HADN¿T BEEN USING BETADINE, BECAUSE THAT IS HONESTLY THE ONLY OTHER THING I CAN THINK OF AND WE HAVEN¿T FOUND ANY OTHERS WITH THIS. ADDITIONAL INFORMATION (CUSTOMER RESPONSE): I SPOKE WITH THE NURSE WHO FOUND THE ISSUE WITH THIS PRODUCT. I ASKED IF SHE HAD BEEN USING BETADINE PRIOR TO OPENING THE PACKAGING OR IF ANY OF THE SURFACES HAD BETADINE ON THEM. SHE STATED THAT SHE WAS WEARING A CLEAN PAIR OF GLOVES, NO ONE WAS USING BETADINE NOR WAS THERE BETADINE ON ANY OF THE SURFACES, AND THEY WERE SPIKING A BAG OF FLUID FOR A PERIPHERAL IV NOT A CENTRAL LINE. THE NURSE OPENED THE PACKAGING WENT TO REMOVE THE SPIKE CAP AND SAW THE BROWN RESIDUE IMMEDIATELY, SO PLACED IT BACK IN THE PACKAGE AND THEN INTO MY BOX. SHE SAID THE NEXT PRODUCT SHE OPENED W

  Patient problems: No Patient Involvement

  MAUDE report 10422653 ↗
• MalfunctionJan 26, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SMARTSITE BURETTE INFUSION SET CRACKED AT THE "BLUE HUB" AND LEAKED TPN SHORTLY AFTER THE INFUSION WAS INITIATED. IT WAS REPORTED BY THE RN THAT THE INFANT DID NOT RECEIVE TPN DUE TO THE EVENT. THERE WAS NO REPORT OF ADVERSE EFFECTS REPORTED BY THE CUSTOMER. THE EVENT OCCURRED IN THE NICU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8280231 ↗
• InjuryJan 24, 2019Crack; Fluid/Blood Leak; Insufficient Flow or Under Infusion; Crack; Fluid/Blood Leak; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED THAT THE SMARTSITE BURETTE INFUSION SET CRACKED NEAR THE UPPER FITMENT AND LEAKED TPN IN THE NICU; AS A RESULT, THE INFANT DID NOT RECEIVE THEIR SCHEDULED TPN DOSE. A NOTE ATTACHED TO THE RECEIVED PRODUCT STATED THE TUBING WAS PUNCTURED INSIDE THE PUMP, AND NOTICED WHEN THE PUMP WAS BEING CLEARED. THE INFANT RECEIVED A FULL IV FLUID AND TUBING CHANGE, AS WELL AS A DOSE OF PROPHYLACTIC VANCOMYCIN.

  Patient problems: Electrolyte Imbalance

  MAUDE report 8276695 ↗