Alaris, SmartSite 20028ERecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07613203012393), received between Aug 10, 2018 and Oct 2, 2023 — classified as 3 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: AMIODARONE INFUSION CAN LEACH DEHP FROM THE ADMINISTRATION SET AND CAUSE IT TO BE INFUSED INTO THE PATIENT. DEHP MAY BE A CARCINOGEN. OUR STAFF MISUNDERSTOOD THE BD PACKAGING (SEE PICTURE) AND THOUGHT THAT THE EXTENSION SET WITH A FILTER DIDN'T CONTAIN DEHP. SEVERAL PHARMACY STAFF MEMBERS VOICED CONCERN THAT IT CONTAINED DEHP, ONLY TO BE REASSURED BY PHARMACISTS THAT IT DIDN'T. THE PHARMACISTS EXPLAINED THAT THE SYMBOLS ON THE PACKAGE WERE ONLY A GLOSSARY, AND THAT THIS DIDN'T MEAN THAT THERE WAS ACTUALLY DEHP IN THE TUBING. FINALLY, A NEW PHARMACIST WAS CHECKING AN AMIODARONE INFUSION, AND SPOKE UP TO SAY " I THINK THIS CONTAINS DEHP". A CALL TO THE MANUFACTURER CONFIRMED THAT IT DOES.

  Patient problems: Chemical Exposure

  MAUDE report 17851210 ↗
• MalfunctionSep 25, 2023Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 17814551 ↗
• MalfunctionAug 29, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING AT THE CONNECTION OF THE TUBING AND THE COLLAR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY CONTINUE TO HAVE ISSUES W/ THESE ME2020 60 INCH BD MAXGUARD MICROBORE TUBING. VERBATIM: ¿ CAN YOU PLEASE PROVIDE MORE DETAILS REGARDING THE FAILURE/ISSUE REPORTED? ALSO, SOME WERE LEAKING AROUND WHERE THE TUBING GOES INTO THE COLLAR. ¿ ARE YOU ABLE TO ADVISE THE OCCURRENCE DATE(S)? JANUARY 2023 TO PRESENT ¿ IF THERE WAS PATIENT INVOLVEMENT, WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? NO HARM ¿ WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? NO, OTHER THAN THE NURSE HAVING TO GO GET ADDITIONAL TUBING. ADDITIONALLY, THE COLLAR NOT BEING STATIONARY RESULTED IN THE COLLAR MIGRATING DOWN THE TUBING MAKING IT HARD TO ATTACH AND WAS CONCERNING AS THIS CAUSES RISK OF CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647403 ↗
• MalfunctionAug 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED WHILE USING BD 17 INCH EXT W/.2 FLTR & VLV PORT THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE 3 LOW SORB FILTERS WITH KINKS, MFR# 20028, AND AVAILABLE FOR RETURN FROM THE SAME LOT # (10)23019359. INCIDENT REPORT:¿ WHILE PRIMING A 0.2 MICRON LOW PROTEIN BINDING FILTER FOR A PATIENT ABOUT TO RECEIVE A PACLITAXEL INFUSION, RN NOTICED A DEFECTIVE PIECE IN THE TUBING RIGHT NEXT TO FILTER. TUBING AREA LOOKED FRAIL AND WAS EASILY CAUSING A KINK IN LINE. RN QUICKLY GRABBED ANOTHER FILTER WITH THE SAME LOT NUMBER AND NOTICED THE SAME DEFECT. LOT # (10)23019359.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450190 ↗
• MalfunctionAug 3, 2023Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED WHILE USING BD 17 INCH EXT W/.2 FLTR & VLV PORT THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE 3 LOW SORB FILTERS WITH KINKS, MFR# 20028, AND AVAILABLE FOR RETURN FROM THE SAME LOT # (10)23019359. INCIDENT REPORT:¿ WHILE PRIMING A 0.2 MICRON LOW PROTEIN BINDING FILTER FOR A PATIENT ABOUT TO RECEIVE A PACLITAXEL INFUSION, RN NOTICED A DEFECTIVE PIECE IN THE TUBING RIGHT NEXT TO FILTER. TUBING AREA LOOKED FRAIL AND WAS EASILY CAUSING A KINK IN LINE. RN QUICKLY GRABBED ANOTHER FILTER WITH THE SAME LOT NUMBER AND NOTICED THE SAME DEFECT. LOT # (10)23019359.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450189 ↗
• MalfunctionJun 19, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE EXTENSION SET THE TUBING WAS DAMAGED. THIS OCCURRED TWICE. THIS IS REPORT 1 OF 2. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DATE:5/23/2023 ¿THIS FILTER HAD 2 TWISTED AND KINKED AREAS IN THE TUBING. THIS CAUSED AN OCCLUSION ALARM ON THE ALARIS PUMP AND NURSE CHANGED THE TUBING. NS WAS FLOWING THROUGH THE TUBING AT THE TIME.¿ PRODUCT: MFR 20028E, AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 17159524 ↗
• MalfunctionJun 19, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE EXTENSION SET THE TUBING WAS KINKED. THIS OCCURRED TWICE. THIS IS REPORT 2 OF 2. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DATE:(B)(6) 2023. ¿THIS FILTER HAD 2 TWISTED AND KINKED AREAS IN THE TUBING. THIS CAUSED AN OCCLUSION ALARM ON THE ALARIS PUMP AND NURSE CHANGED THE TUBING. NS WAS FLOWING THROUGH THE TUBING AT THE TIME.¿. PRODUCT: MFR 20028E, AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 17159522 ↗
• MalfunctionMay 1, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 6 OF THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN EXPERIENCING SOME ISSUES WITH OUR .2 MICRON FILTER NOT PRIMING. THE RN WILL ATTEMPT TO PRIME THE MEDICATION, BUT IT WILL STOP WHEN IT GETS TO THE FILTER. THE RN WILL THEN HOOK UP A 10ML NORMAL SALINE SYRINGE AND TRY TO PRIME BUT IS MET WITH RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16849321 ↗
• MalfunctionApr 4, 2023Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FILTER SEPARATED FROM THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET DURING THE INFUSION, CAUSING CHEMOTHERAPY TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FAULTY FILTER. FILTER POPPING OFF IN THE MIDDLE OF THE INFUSION... ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER (B)(6) 2023. PER CUSTOMER "THE FAILURE IN THE FILTERS RESULTED IN MULTIPLE CHEMO SPILLS, WHICH IN TURN MEANS THE PATIENT DID NOT GET THEIR FULL DOSE OF MEDICATION"".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16677001 ↗
• MalfunctionMar 15, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET WAS BLOCKED AT THE FILTER DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD SOME FILTERS (20028E) THAT ARE NOT ALLOWING FLUID TO PASS THRU."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550893 ↗
• MalfunctionJan 28, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE EXTENSION SET THERE WAS DAMAGE TO THE CLAMP AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIMARY RN REPORTING BLOOD COMING FROM PT'S PICC LINE. UPON EVALUATION FROM PRIMARY RN TPN FILTER TUBING HAD BROKEN. PICC LINE WAS IMMEDIATELY CLAMPED. LEUR LOCK WAS STILL ATTACHED TO THE PT'S PICC LINE FROM THE FILTER TUBING. THE TUBING BROKE RIGHT AFTER THE LEUR LOCK. PT WAS BLEEDING FROM THE PICC LINE SINCE THE CLAMP WAS NOT CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261496 ↗
• MalfunctionJan 23, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET TUBING WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE SAVED SOME FAULTY TUBING IN WHICH A RL REPORT WAS PLACED"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231042 ↗
• MalfunctionSep 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET DISCONNECTED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HANGING PATIENT¿S SHEETS AND NOTICED TOTAL PARENTERAL NUTRITION (TPN) FILTER WAS DRIPPING FLUIDS. THE TUBING THAT WAS CONNECTED TO THE FILTER COMPLETELY DISCONNECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15471011 ↗
• MalfunctionAug 16, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 2 BD SMARTSITE¿ EXTENSION SETS WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CANNOT FLUSH THROUGH EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235201 ↗
• MalfunctionJul 15, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CANNOT FLUSH THROUGH EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033945 ↗
• MalfunctionJul 8, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET WAS CLOGGED AND COULD NOT PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT COULD NOT PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959353 ↗
• MalfunctionJun 30, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WOULD NOT FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EXTENSION SET WOULD NOT FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881064 ↗
• MalfunctionJun 24, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY CAN NOT FLUSH THROUGH THE EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802149 ↗
• MalfunctionJun 16, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED AIR IN THE FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY TEAM HAS BROUGHT TO MY ATTENTION THAT TPN FILTERS WE ARE USING ARE EXTREMELY DIFFICULT TO ASSURE THERE IS NO AIR IN THE FILTER, AS THEY NOTE THAT THE AIR WILL MOVE OUT OF THE FILTERS AND TO THE TUBING LEADING TO POTENTIAL AIR TO THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714000 ↗
• MalfunctionApr 26, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AT THE TUBING CONNECTION TO THE FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV FILTER FLUID LEAKING WHERE TUBING MEETS FILTER REQUIRING NEW LINES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14211933 ↗
• MalfunctionMar 17, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV FILTER FLUID WAS LEAKING WHERE TUBING MEETS FILTER REQUIRING NEW LINES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13794594 ↗
• MalfunctionMar 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED BD ALARIS SMARTSITE EXTENSION SET HAD A LEAKAGE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...THE IV FILTER FLUID LEAKING WHERE TUBING MEETS FILTER REQUIRING NEW LINES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13761142 ↗
• MalfunctionNov 11, 2021Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED WHEN USING THE BD 17 INCH EXT W/.2 FLTR & VLV PORT, THE DEVICE EXPERIENCED AIR BUBBLES IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THE FILTER IS NOT FILTERING. WE ARE STILL HAVING ISSUES WITH THE 0.2-MICRON FILTERS NOT FILTERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800997 ↗
• MalfunctionOct 29, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USER UNABLE TO FLUSH 0.2 MICRON FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721566 ↗
• InjuryAug 26, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 17 INCH EXT W/.2 FLTR & VLV PORT WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 20028E, BATCH NO: UNKNOWN. IT WAS REPORTED SMART SITE EXTENSION FILTER CRACKED WITH LEAKAGE; BABY HAD ELECTROLYTE ISSUES.

  Patient problems: Electrolyte Imbalance

  MAUDE report 10457027 ↗