Alaris, SmartSite 47233ERecalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve 2 Needle-Free Valves, Vented/ Nonvented, 264 cm (104 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885403235443), received between Aug 12, 2020 and Mar 11, 2024 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash4
- Material Separation3
- Air/Gas in Device1
- Break1
- Component Missing1
- Detachment of Device or Device Component1
- Device Markings/Labelling Problem1
- Improper Flow or Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information1
- No Patient Involvement1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18883015 ↗MalfunctionFeb 13, 2024Separation Problem; Separation Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18694303 ↗MalfunctionJan 2, 2024Break; Break
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: CUSTOMER HAD A PRODUCT ISSUE WITH 47233E. THIS IS WHAT I RECEIVED FROM OUR REPORTER: ¿IV GRAVITY TUBING THAT PIECES WERE POPPING OFF; THE SPIKE PIECE AND WHERE THE PORT ATTACHED TO FURTHER TUBING¿. I HAVE THREE IN MY OFFICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18427575 ↗MalfunctionOct 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION: IT WAS REPORTED THE BD GRAVITY ADMINISTRATION SET SEPARATED WHILE BEING USED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: "TUBING COMING APART; I BELIEVE AT THE DRIP CHAMBER".
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17901553 ↗MalfunctionMay 17, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET TUBING SEPARATED FROM THE CHAMBER AND LEAKED OUT FLUID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING CAME OFF FROM PRIMING CHAMBER AND IS A CLEAN BREAK. FLUID DRIPPED EVERYWHERE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16950968 ↗MalfunctionMar 27, 2023Component Missing; Component Missing
IT WAS REPORTED THAT 3 BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED ROLLER CLAMP MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCOUNT STATES THA ITEM #47233E IS MISSING ROLLER CLAMP AND HAS EXCESSIVE BUBBLES IN LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16619957 ↗MalfunctionMar 27, 2023Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED, THAT 3 BD ALARIS SMARTSITE GRAVITY SET, EXPERIENCED AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED, BY THE INITIAL REPORTER: ACCOUNT STATES, THAT ITEM #47233E IS MISSING ROLLER CLAMP. AND HAS EXCESSIVE BUBBLES IN LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16619956 ↗MalfunctionFeb 16, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16390345 ↗MalfunctionFeb 16, 2023Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET WOULD NOT FLOW DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I NOW HAVE ANOTHER ONE OF YOUR PRODUCTS THAT IS NOT FLOWING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16390335 ↗MalfunctionFeb 16, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET TUBING WAS "STIFF" AND DIDN'T CONNECT WELL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TUBING IS NOW MORE STIFF AND NOT CONNECTING WELL".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16390332 ↗MalfunctionDec 20, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT THE GRAVITY ADMINISTRATION SETS CAME APART AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING AND CAME APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16018428 ↗MalfunctionMar 8, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT 5 BD ALARIS SMARTSITE GRAVITY BLOOD SETS EXPERIENCED KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING IS CRIMPED AND DOESN'T ALLOW FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13691025 ↗MalfunctionAug 12, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT 1008-000-072 PRODUCTS WERE RECEIVED RATHER THAN 47233E - GRAVITY SET 60DP CKV 2SMS DEHP FREE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 47233E, BATCH NO: UNKNOWN. IT WAS REPORTED THE CUSTOMER RECEIVED THE WRONG ITEMS IN THE PACKAGE. BD ACCT EXECUTIVE 21 JUL 2020 AT 7:41 PM: WE WERE SUPPOSED TO SEND 47233E. WHAT ARRIVED WAS 1008-000-072. ONE BOX HAD THE RIGHT PRODUCT CODE ON IT 47233E, BUT THE CONTENTS WERE 1008-000-072. BD ACCOUNT EXEC: 21 JUL 2020 AT 3:29 PM: CUSTOMER WAS IN DIRE NEED OF THIS PRODUCT AND WE SENT THE WRONG PRODUCT. WE DID SO W/ 2 CASES, AND 1 CASE SAID IT WAS THE RIGHT PRODUCT WITH THE WRONG ITEM IN IT. BD ACCOUNT EXEC: 21 JUL 2020 AT 12:38PM: CUSTOMER JUST CALLED VERY DISAPPOINTED AS THEY SAID 3 CASES OF LUER CAPS ARRIVED, AND IT APPEARS THE WRONG PRODUCT WAS SENT. IT WAS A PRODUCT # I DON¿T SEE IN OUR CATALOG, 108000072. BD ACCT EXECUTIVE 21 JUL 2020 AT 12:24 PM: SHIPMENT ARRIVED, BUT TWO OF THE CASES WERE THE WRONG ITEM, AND ONE OF THE CASES HAS A STICKER AS THOUGH IT¿S THE RIGHT ITEM BUT HAS THE SAME LUERS IN THE BOX.
Patient problems: No Patient Involvement
MAUDE report 10400031 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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