Alaris, SmartSite 10012564Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10885403233746), received between May 7, 2021 and Nov 4, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT BD SMARTSITE GRAVITY BURETTE SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: I HOPE YOU ARE WELL. OUR ANESTHESIA TEAM IS EXPERIENCING QUALITY ISSUES WITH AT LEAST 8 BURETROLS (REF# (B)(4)) ENTRAINING AIR. WE HAVE 597 EA IN OUR WAREHOUSE. ARE WE ABLE TO INITIATE A RMA FOR UNOPENED BOXES OF BURETROLS?

  Patient problems: Insufficient Information

  MAUDE report 18070309 ↗
• MalfunctionJul 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED WHILE USING BD GRAVITY BURETTE SET 60 DP 3 SMARTSITE THE TUBING RUPTURED. THIS OCCURRED 7 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: NO ITEM: 10012564 QUANTITY AFFECTED: 7 EACH SERIAL/LOT NUMBER: (B)(6) PO : 4516069865 ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: EXPLODING. CUSTOMER DISPOSITION REQUEST: CREDIT.

  Patient problems: Insufficient Information

  MAUDE report 17259588 ↗
• MalfunctionJun 29, 2023Material Deformation; Material Deformation

  IT WAS REPORTED WHILE USING BD SMARTSITE¿ GRAVITY BURETTE SETS TUBING WAS KINKING. THIS OCCURRED (B)(4) TIMES. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: KINKED TUBING ISSUE WAS OBSERVED NEAR TO THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224299 ↗
• MalfunctionJun 16, 2023Defective Device; Defective Device

  IT WAS REPORTED WHILE USING BD SMARTSITE GRAVITY BURETTE SET THE DEVICE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN FLUID PLACED IN BURETROL BOTTOM IS POPPING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148700 ↗
• MalfunctionMay 18, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED WHILE USING BD SMARTSITE¿ GRAVITY BURETTE SET THE CONNECTION WAS SEPARATED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD MULTIPLE REPORTS OF BURETROLS FALLING ABOUT FROM OUR ANESTHESIA DEPARTMENT. I HAVE NOT RECEIVED THE REF BUT I DO HAVE THE LOT# IF YOU ARE ABLE TO LOOK THAT UP. WE WERE ASKED TO PULL ALL PRODUCT WITH THAT LOT NUMBER, BUT WAITING TO HEAR BACK ON IF THAT IS THE ONLY LOT WE HAVE ON HAND. THE IV CAME APART WITHIN 5 MINUTES OR LESS ONCE IT WAS CONNECTED TO THE PATIENT. NO MEDICATION INFUSED. NO PATIENT HARM. WAS THERE ANY LEAKAGE FOUND DURING THE INCIDENT? I¿M NOT SURE WHAT THE ASK IS. THE BURETROL FELL APART SO YES THERE WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959269 ↗
• MalfunctionMay 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PIECE OF THE BD SMARTSITE¿ GRAVITY BURETTE SET SEPARATED FROM THE SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PIECE.... POPPED OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934227 ↗
• MalfunctionFeb 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD SMARTSITE¿ GRAVITY BURETTE SET TUBING DETACHED FROM THE Y-SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON REMOVAL FROM PACKAGING. THE IV SET WAS INSPECTED PRIOR TO PATIENT USE. THE TUBING WAS DETACHED FROM THE Y CONNECTION OF THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329959 ↗
• MalfunctionJan 18, 2023Detachment of Device or Device Component

  UPON REMOVAL FROM PACKAGING. THE IV SET WAS INSPECTED PRIOR TO PATIENT USE. THE TUBING WAS DETACHED FROM THE Y CONNECTION OF THE TUBING.

  Patient problems: Insufficient Information

  MAUDE report 16194032 ↗
• MalfunctionOct 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ LVP 20D LOW SORB SS 0.2M EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE MIDDLE OF THE CASES THE BURETTE IV SET SPLIT INTO TWO PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544568 ↗
• MalfunctionSep 26, 2022Misassembled; Misassembled

  IT WAS REPORTED THAT 4 BD ALARIS¿ LVP 20D LOW SORB SS 0.2M ARE MISSING THE SMALL BLUE BALL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PCT NOTICED WHILE PRIMING TUBING FOR HEMODIALYSIS THAT A PIECE IN THE FILL CHAMBER (SMALL BLUE BALL) WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487053 ↗
• MalfunctionJul 21, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT 3 BD SMARTSITE GRAVITY BURETTE SET EXPERIENCED COMPONENT SEPARATION AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BOTTOM BLOWS OFF WHEN THE NURSE SQUEEZES THE IV FLUID INTO IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080739 ↗
• MalfunctionSep 8, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BOTTOM OF THE GRA SET V/NV QS MC 60D 3SS BURETTE WAS LOOSE AND SEPARATED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE ONLY ADVERSE RESPONSE FROM THIS FAULT IS THAT A GIANT MESS IS CREATED THAT HAS TO BE CLEANED AND FLUIDS HAVE TO BE ADMINISTERED AGAIN WITH A NEW IV KIT. THANKFULLY NO PATIENTS HAVE BEEN NEGATIVELY AFFECTED BY THIS FAULT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439702 ↗
• MalfunctionAug 31, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 GRA SET V/NV QS MC 60D 3SS EXPERIENCED COMPONENT SEPARATION, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROBLEM WE ARE HAVING IS THE BOTTOM OF THE BURETTE IS NOT ATTACHED FIRMLY, SO THAT WHEN AN IV FLUID IS FED INTO THE BURETTE THE BOTTOM FALLS OFF AND THE FLUID SPILLS ALL OVER THE FLOOR. NORMALLY THE BURETTE IS ATTACHED TO A PLASTIC SEAL THAT CONNECTS TO A BALL VALVE CHAMBER THAT HAS A FIRM SEAL, BUT WE HAVE HAD 2 COMPLAINTS IN A WEEK OF THE THIS ISSUE HAPPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389718 ↗
• MalfunctionAug 4, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE GRA SET V/NV QS MC 60D 3SS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANESTHESIA HAS HAD ISSUES WITH BURETTE GRAVITY SETS MFR# (B)(4) LEAKING AT THE BOTTOM OF THE CHAMBER WHERE THE TUBING HOOKS UP TO IT. THEY ARE REFUSING TO USE ANY OF THE BELOW PRODUCT LOT #.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277486 ↗
• MalfunctionJun 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE GRA SET V/NV QS MC 60D 3SS SEPARATED FROM THE CONTAINER DURING USE WHEN PRESSURE WAS USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHITE BOTTOM OF THE BURETROL SEPARATES FROM THE CONTAINER WHEN PRESSURE IS APPLIED"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980327 ↗
• MalfunctionJun 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BOTTOM OF THE GRA SET V/NV QS MC 60D 3SS BURETROL SEPARATED FROM THE CONTAINER WHEN PRESSURE WAS USED ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE WHITE BOTTOM OF THE BURETROL SEPARATES FROM THE CONTAINER WHEN PRESSURE IS APPLIED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968611 ↗
• MalfunctionJun 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A GRA SET V/NV QS MC 60D 3SS EXPERIENCED COMPONENT SEPARATION AND LEAKAGE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE BOTTOM OF THE TUBE WOULD EITHER LEAK REALLY BAD OR JUST POP OFF LIKE THERE IS NO GLUE ON IT. THEY DID CHECK THE PRODUCT PRIOR TO SPIKING THE IV AND STATED IT SEEMED TO BE FINE, BUT AFTER THE IV FLUID SAT IN THERE FOR A LITTLE BIT THE BOTTOM CAME OFF OR STARTED LEAKING REALLY BAD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925071 ↗
• MalfunctionJun 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE GRA SET V/NV QS MC 60D 3SS LEAKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY JUST TOLD ME THAT WE HAVE HAD SEVERAL OF THEM LEAKING TODAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917986 ↗
• MalfunctionMay 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 GRA SETS V/NV QS MC 60D 3SS LEAKED FROM THE BOTTOM OF THE TUBE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BOTTOM OF THE TUBE WOULD EITHER LEAK REALLY BAD OR JUST POP OFF LIKE THERE IS NO GLUE ON IT. THEY DID CHECK THE PRODUCT PRIOR TO SPIKING THE IV AND STATED IT SEEMED TO BE FINE, BUT AFTER THE IV FLUID SAT IN THERE FOR A LITTLE BIT THE BOTTOM CAME OFF OR STARTED LEAKING REALLY BAD. OUR DOCTORS ARE VERY CONCERNED REGARDING THIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823128 ↗
• MalfunctionMay 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT GRA SET V/NV QS MC 60D 3SSTUBING BROKE. THIS OCCURRED ON 10 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10012564 BATCH NO: 20096477. IT WAS REPORTED THAT THE BOTTOM PIECE ON THE TUBE COMES OFF DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794877 ↗