Alaris, SmartSite 2432-0007Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 Y-Sites, 297 cm, (117 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Alaris SmartSite infusion set is an intravenous tubing set used with infusion pumps. Most reports describe leaks, with fluid escaping from ports or filters, and some describe blockages, separated material or air in the tubing. There are 258 reports, with no deaths and 2 injuries. 2 recalls are open, over performance data for infusion sets and pumps that may work outside set ranges for flow and dose accuracy.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 256
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 256 adverse event reports that list this exact device (DI 10885403232329), received between Aug 9, 2018 and Sep 28, 2026 — classified as 2 injuries, 254 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (110 reports).
2 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.
Reports received per month
Recalls naming this device
- 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 ↗
- Jul 8, 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-2180-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash110
- Fluid/Blood Leak40
- Complete Blockage17
- Material Separation13
- Air/Gas in Device11
- Disconnection11
- Backflow10
- Free or Unrestricted Flow10
Patient problems
- No Clinical Signs, Symptoms or Conditions162
- No Consequences Or Impact To Patient57
- Insufficient Information18
- No Information16
- No Known Impact Or Consequence To Patient3
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 256 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Leak/Splash
It was reported that BD alaris smartsite pump infusion set was leaking.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that the tubing that have leaked at the filter when priming.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917197 ↗MalfunctionSep 15, 2026Free or Unrestricted Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775087 ↗MalfunctionJul 4, 2026Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WHILE PRIMING NEW PRECEDEX DRIP, A PORT STARTED DRIPPING MEDICATION. I EXCHANGED THE DEFECTIVE TUBING WITH NEW TUBING. THIS IS THE SECOND SET OF THE SAME ITEM NUMBER TO LEAK IN TWO WEEKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25710679 ↗MalfunctionJun 19, 2026Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THERE WAS LEAKING FROM ONE OF THE MICROCLAVE / Y-SITE PORT OF THE TUBING WHERE SECONDARY LINES WOULD BE CONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25564245 ↗MalfunctionJun 16, 2026Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV FILTERED LINE PREPARED FOR TREATMENT WITH SALINE BAG. NOTED SALINE POURING DIRECTLY OUT OF HOLE IN FILTER. CLAMPED AND SENT TO BIOMEDICAL WITH PACKAGING IT CAME FROM. DID NOT IMPACT PATIENT, BUT IF NOT CAUGHT EARLY OR OCCURS MIDWAY THROUGH CHEMOTHERAPY INFUSION, THIS CAN CAUSE SERIOUS HARM TO PATIENT OR EXPOSURE TO STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523291 ↗MalfunctionApr 17, 2026Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS EVENT WAS REPORTED AS A RETROSPECTIVE EVENT AND WAS NOT OBSERVED AND REPORTED IN REAL TIME. THIS PATIENT HAD BEEN RECEIVING IV FENTANYL FROM 1/12 - 1/15. IT WAS NOT UNTIL 1/15 THAT THERE WAS A FENTANYL WASTE DISCREPANCY. PER THE ICU MANAGER, AFTER A FEW DISCREPANCIES WITH IV FENTANYL, DURING HUDDLE SHE TOLD THE TEAM TO REPORT IF THERE WERE ANY DISCREPANCIES NOTICED WITH INSULIN OR PRESSORS. AT THAT TIME WAS WHEN THE NIGHT SHIFT CHARGE NURSE STATED THAT THEY HAD TO CHANGE THE PATIENTS IV LEVOPHED FROM THE OCTO-LEVO CONCENTRATION BACK DOWN TO THE DOUBLE CONCENTRATION BECAUSE HIS BLOOD PRESSURE WAS ALL OVER THE PLACE. SHE REPORTED THAT THERE WERE LESS ISSUES ON THE LOWER CONCENTRATION, BUT THE PATIENT WAS STILL VERY ILL. SHE THEN STATED THAT DURING THE SAME HUDDLE, THE DAY SHIFT NURSE COMMENTED, THIS WAS HAPPENING TO ME WITH HIM YESTERDAY AND I JUST ASSOCIATED IT WITH CHANGING HIM OR MOVING HIM. IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY STARTED ON AN IV LEVOPHED INFUSION THAT WAS A DOUBLE CONCENTRATION OF 32 MCG/ML (8MG IN 250ML). F
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24906334 ↗MalfunctionApr 16, 2026Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN DISCUSSION WITH A BEDSIDE NURSE, SHE STATED THAT A "FEW FILTERS HAD HOLES AND LEAKED". PER THE NURSE, THESE INSTANCES OCCURRED A FEW MONTHS AGO AND HAVE NOT OCCURRED SINCE. IT WAS ONLY NOTICED WHEN SHE WAS PRIMING A DRUG OR FLUID AND DID NOT EVER LEAK WHEN THEY WERE CONNECTED TO A PATIENT. SHE SPECIFICALLY REMEMBERS SHE WAS PRIMING AND ANTIBIOTIC AND ALL OF A SUDDEN HER WHOLE HAND WAS WET. HAD TO DISCARD TUBING. STATED THAT THE TUBING WAS THE "NORMAL TUBING WITH INLINE FILTER" BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER. REF: 2432-0007 THE ICU MANAGER HAS BEEN UNABLE TO ORDER IV PUMP TUBING WITHOUT SMART SITES. THIS IS WHY THE STAFF HAS BEEN USING THE IV PUMP INFUSION SET WITH SMART SITES FOR NARCOTICS. THE DATE THIS HAPPENED ACCORDING TO THE INFORMATION DISPLAYED ON THIS TAB FROM PHARMACY JAN 4, 2026 THE DATE OF KNOWLEDGE IS MARCH 24, 2026. ACCORDING TO THE INFORMATION PROVIDED BY PHARMACY, THERE WAS A FENTANYL WASTE DISCREPANCY OF 122MLS. PATIENT INVOLVEMENT, ISSUE WAS NOT FOUND IN REAL TIME BUT FOUND MULTIPLE DAYS AFTER INFUSIONS STARTE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899356 ↗MalfunctionApr 16, 2026Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN DISCUSSION WITH A BEDSIDE NURSE, SHE STATED THAT A "FEW FILTERS HAD HOLES AND LEAKED". PER THE NURSE, THESE INSTANCES OCCURRED A FEW MONTHS AGO AND HAVE NOT OCCURRED SINCE. IT WAS ONLY NOTICED WHEN SHE WAS PRIMING A DRUG OR FLUID AND DID NOT EVER LEAK WHEN THEY WERE CONNECTED TO A PATIENT. SHE SPECIFICALLY REMEMBERS SHE WAS PRIMING AND ANTIBIOTIC AND ALL OF A SUDDEN, HER WHOLE HAND WAS WET. HAD TO DISCARD TUBING. STATED THAT THE TUBING WAS THE "NORMAL TUBING WITH INLINE FILTER" BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER. REF: 2432-0007 THE ICU MANAGER HAS BEEN UNABLE TO ORDER IV PUMP TUBING WITHOUT SMART SITES. THIS IS WHY THE STAFF HAS BEEN USING THE IV PUMP INFUSION SET WITH SMART SITES FOR NARCOTICS. THE DATE THIS HAPPENED ACCORDING TO THE INFORMATION DISPLAYED ON THIS TAB FROM PHARMACY ON (B)(6) 2026 THE DATE OF KNOWLEDGE IS MARCH 24, 2026. ACCORDING TO THE INFORMATION PROVIDED BY PHARMACY, THERE WAS A FENTANYL WASTE DISCREPANCY OF 122MLS. PATIENT INVOLVEMENT, ISSUE WAS NOT FOUND IN REAL TIME BUT FOUND MULTIPLE DAYS AFTER INFUSIONS ST
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899355 ↗MalfunctionApr 16, 2026Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN DISCUSSION WITH A BEDSIDE NURSE, SHE STATED THAT A "FEW FILTERS HAD HOLES AND LEAKED". PER THE NURSE, THESE INSTANCES OCCURRED A FEW MONTHS AGO AND HAVE NOT OCCURRED SINCE. IT WAS ONLY NOTICED WHEN SHE WAS PRIMING A DRUG OR FLUID AND DID NOT EVER LEAK WHEN THEY WERE CONNECTED TO A PATIENT. SHE SPECIFICALLY REMEMBERS SHE WAS PRIMING AND ANTIBIOTIC AND ALL OF A SUDDEN, HER WHOLE HAND WAS WET. HAD TO DISCARD TUBING. STATED THAT THE TUBING WAS THE "NORMAL TUBING WITH INLINE FILTER" BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER. REF: 2432-0007. THE ICU MANAGER HAS BEEN UNABLE TO ORDER IV PUMP TUBING WITHOUT SMART SITES. THIS IS WHY THE STAFF HAS BEEN USING THE IV PUMP INFUSION SET WITH SMART SITES FOR NARCOTICS. THE DATE THIS HAPPENED ACCORDING TO THE INFORMATION DISPLAYED ON THIS TAB FROM PHARMACY ON (B)(6) 2026. THE DATE OF KNOWLEDGE IS ON (B)(6) 2026. ACCORDING TO THE INFORMATION PROVIDED BY PHARMACY, THERE WAS A FENTANYL WASTE DISCREPANCY OF 122MLS. PATIENT INVOLVEMENT, ISSUE WAS NOT FOUND IN REAL TIME BUT FOUND MULTIPLE DAYS AFTER INFUSIONS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899005 ↗MalfunctionApr 15, 2026Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS INFORMATION WAS WHAT THE HOSPITAL TEAM TOLD BD DURING THE MEETING. PER THE TEAM, A 250ML FENTANYL BAG HAD EMPTIED IN 11 HOURS AND THERE WAS ABOUT 200MLS MISSING. AT THE TIME OF THE EVENT, THERE WERE NO LOCK BOXES AROUND THE NARCOTIC AND THE TUBING USED WAS BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER. REF: 2432-0007. IT WAS STATED THAT IT IS RARE FOR AN ICU PATIENT TO BE ON A PCA. THE TUBING WAS SEQUESTERED AND OBSERVED ON SITE. THERE WAS SEDIMENT IN THE PUMPING SEGMENT AND AN INDENTATION ON THE UPPER END. THERE WAS A STICKER PLACED ON THE TUBING THAT INCLUDED THE DRUG NAME, GENERIC AND BRAND NAME, THE TIME, THE CHANGE DAY AND TIME, AND A WARNING. IT WAS REPORTED THAT THE IV PUMP TUBING HAD BEEN LOADED IN THE PUMP MODULE SINCE THE EVENT, WHICH WAS OVER 2 MONTHS AGO. IT WAS REPORTED THAT DURING HANDOFF THE NURSES LOOKED AT THE BAG AND NOTICED IT WAS LESS THAN EXPECTED. THIS PATIENT WAS INTUBATED AND SEDATED WITH EVIDENCE OF DETERIORATION. THE PATIENT WAS HOOKED UP TO THE CARDIAC MONITOR AND THE PULSE OXIMETER. THE MANAGER WAS UNSURE OF
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24891313 ↗MalfunctionMar 11, 2026Crack
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24576413 ↗MalfunctionMar 11, 2026Separation Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572032 ↗MalfunctionMar 10, 2026Fluid/Blood Leak; Leak/Splash
AT END OF YERVOY INFUSION, APPROX. 5ML OF DRUG LEAKED FROM FILTER TUBING ONTO PT. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559253 ↗MalfunctionFeb 12, 2026Obstruction of Flow
IT IS REPORTED, FLOW ISSUES OCCLUSION. DESCRIPTION: PRIMED FILTER TUBING(BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER REF2432-0007) WITH PEMGARDA, BUT THE DRUG WOULD NOT PASS THE FILTER BY GRAVITY. ATTEMPTED TO PRIME USING PUMP, BUT STILL DID NOT WORK. UNABLE TO SALVAGE DRUG DT TUBING ISSUE, SO PHARMACY HAD TO MAKE ANOTHER DOSE. PT WOULD HAVE RECEIVED THE MEDICINE AT 1512 AND IT WAS DELAYED UNTIL 1543. THERE'S AT LEAST TWO OTHER SIMILAR OCCURRENCES BUT THE TEAM DIDN'T ENTER A REPORT AT THE TIME THEY OCCURRED. I KNOW THAT'S NOT VERY HELPFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326372 ↗MalfunctionFeb 12, 2026Obstruction of Flow
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326362 ↗MalfunctionJan 29, 2026Crack
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR CARE TEAMS HAVE IDENTIFIED A TREND INVOLVING TUBING FAILURES AFFECTING TWO DIFFERENT IV SETS. THESE FAILURES INCLUDE DISCONNECTIONS AND VISIBLE CRACKING IN THE TUBING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? THE TUBING USED FOR LIPIDS HAPPENED (B)(6) 2025 CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT NUMBER IS UNKNOWN, PACKAGING WAS DISCARDED HOURS BEFORE THE BREAK OCCURRED. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM WAS REPORTED, THE BREAK IN THE TUBING OCCURRED WHEN THE RN WAS DISCONNECTING IT FROM THE PATIENT, SO THE PATIENT WAS NOT EXPOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24214946 ↗MalfunctionDec 31, 2025Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FILTER FILLED WITH AIR WHEN PRIMING. INJURIES OR ADVERSE EVENT: NO. ITEM: 2432-0007, QUANTITY AFFECTED: 2EA, SERIAL/LOT NUMBER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936686 ↗MalfunctionDec 31, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS ANOTHER LEAKING INCIDENT WITH THE SAME SKU AND LOT # OF PRIOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934626 ↗MalfunctionDec 31, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN ATTEMPTED TO PRIME FILTERED IV TUBING WITH CHEMO, DACARBAZINE, VIA PUMP PER PROTOCOL. DRUG WOULD NOT PRIME PAST THE FILTER ON THE IV TUBING. RN SOUGHT CN FOR ASSISTANCE. RN CONTACTED PHARMACY AND REVIEWED DRUG INFORMATION, IT IS NOT LISTED AS A "NO FILTER" DRUG. RN AND CN TROUBLESHOOT TUBING AND PUMP WITH NO SUCCESS. PHARMACY CONTACTED TO MAKE NEW BAG OF DRUG. RN THEN ATTEMPTS TO PRIME A NEW SET OF FILTERED TUBING WITH THE OLD BAG OF CHEMO, TO SEE IF THE PROBLEM IS THAT THE DRUG CANNOT BE FILTERED OR IF THAT ONE SPECIFIC IV SET MALFUNCTIONED. THIS ATTEMPT WITH A SECOND IV SET WAS SUCCESSFUL, LEADING US TO BELIEVE THE FIRST IV SET MALFUNCTIONED. AFTER TALKING TO THIS RN AND ANOTHER, THE CN FOUND THAT THIS HAS HAPPENED WITH DIFFERENT DRUGS AND IVFS MULTIPLE TIMES RECENTLY WITH DIFFERENT PATIENTS, BUT NO 360'S WERE COMPLETED. THIS LEADS ME TO BELIEVE WE HAVE A BAD BATCH OF FILTERED IV TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934625 ↗MalfunctionDec 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT HAS EXPERIENCED TWO OCCURRENCES OF LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23880439 ↗MalfunctionDec 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY A CUSTOMER THAT AFTER PRIMING INFUSION SET FILTER NOTED TO BE LEAKING FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23880411 ↗MalfunctionDec 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT HAS EXPERIENCED TWO OCCURRENCES OF LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23880409 ↗MalfunctionDec 11, 2025Break; Break
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING WAS CHANGED AND PORT WAS FLUSHED AND OCCLUSION REOCCURRED AN HOUR LATER, THIS TIME TPN IV TUBING BROKE WHEN REMOVED FROM IV PUMP CHAMBER. THIS RESULTED IN PT NOT RECEIVING SEDATION FOR AN UNKNOWN PERIOD OF TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777480 ↗MalfunctionDec 11, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD A BULGE / BALLOON IN THE SILICONE / PUMP SEGMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TPN BACKED UP AND THE IV TUBING LINE FORMED A BUBBLE INSIDE THE IV PUMP CHAMBER. THIS RESULTED IN PT NOT RECEIVING SEDATION FOR AN UNKNOWN PERIOD OF TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777267 ↗MalfunctionDec 11, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD AN OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OCCLUSION OCCURRED IN PT'S CENTRAL LINE. THIS RESULTED IN PT NOT RECEIVING SEDATION FOR AN UNKNOWN PERIOD OF TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777252 ↗
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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 · each recall links to the FDA recall notice
- 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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