SmartSite 2477-0000Recalls & reported problems
BD Switzerland Sàrl · Blood Infusion Set 309 cm (122 in) · Class 2
All models of SmartSite (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a BD SmartSite blood infusion set, tubing used to give blood transfusions. The 35 reports mostly describe leaking — blood or fluid escaping from the tubing, drip chamber or pumping segment, sometimes because the plastic cracked or the parts separated. Reports also mention air-in-line alarms and faster-than-expected flow. There are no deaths and one injury. One recall, started May 2019 and closed, involved wall thickness in the pumping segment that could allow medication or blood to be delivered when the pump isn't running.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07613203011310), received between Jun 11, 2018 and Jan 30, 2024 — classified as 1 injury, 34 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (30 reports).
1 FDA recall record name this device's identifier.
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
- May 6, 2019Class ITerminated
An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.
Z-1770-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak30
- Material Separation5
- Crack1
- Device Alarm System1
- Excess Flow or Over-Infusion1
- Leak/Splash1
- Material Puncture/Hole1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Consequences Or Impact To Patient26
- No Information5
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE BLOOD SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: ON (B)(6) 2023. A PATIENT IN OUR MEDICAL DAY CLINIC WAS RECEIVING A UNIT OF RED BLOOD CELLS AND WHEN THE NURSE WAS DOING THEIR 15 MINUTES POST START OF TRANSFUSION ASSESSMENT NOTED THAT THE TUBING JUST ABOVE THE NONVENTED DRIP CHAMBER WAS LEAKING BLOOD AT 1105H. THE TRANSFUSION WAS STOPPED AND THE UNIT OF RED BLOOD CELLS WITH TUBING WAS SENT BACK TO OUR TRANSFUSION MEDICINE DEPARTMENT. I HAVE REACHED OUT TO THE OUR TRANSFUSION MEDICINE DEPARTMENT TO SEE IF THE TUBING IS STILL AVAILABLE TO SEND BACK TO BD FOR INVESTIGATION AND WILL LET YOU IF IT IS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607395 ↗MalfunctionJul 30, 2019Material Puncture/Hole; Material Puncture/Hole
AN UNEXPECTED RETURN WAS RECEIVED, WITH NO KNOWN COMPLAINT OR ISSUE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: No Information
MAUDE report 8842129 ↗MalfunctionJul 15, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE OUTPATIENT CLINIC NURSE WAS DISCONNECTING THE BLOOD TUBING SET AFTER THE COMPLETION OF A BLOOD TRANSFUSION WHEN THE NURSE NOTICED BLOOD ON HER GLOVE. UPON ASSESSMENT THE TUBING SET APPEARED TO BE CRACKED AND LEAKING FROM THE TOP OF THE DRIP CHAMBER. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE ADULT PATIENT FROM THE EVENT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 8791720 ↗MalfunctionJun 13, 2019Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging; Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging
THE CUSTOMER REPORTED THAT SUPPLY CHAIN RECEIVED A SET FROM THE PICU; THE FAILURE MODE WITH THE SET WAS NOT PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Information
MAUDE report 8695508 ↗MalfunctionMay 29, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT AFTER SPIKING THE BLOOD CONTAINER AND PRIMING THE LINE WITH BLOOD, THE USER INSERTED THE PUMP SEGMENT INTO THE PUMP MODULE AND IDENTIFIED SMALL LEAKS OCCURRING FROM THE PUMPING SEGMENT. THERE WAS NO PATIENT HARM. RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM FDA, WHICH STATES RN SPIKED BLOOD WITH TUBING AND PRIMED IT. WHEN STARTING TO PLACE IN THE CHAMBER IT WAS NOTED IN THE STRETCHY PART THERE WERE SMALL HOLES AND THE BLOOD STARTED TO LEAK OUT ON TO THE FLOOR. TUBING REMOVED FROM THE BLOOD, NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8649252 ↗MalfunctionMay 24, 2019Device Alarm System
PATIENT REQUIRED BLOOD TRANSFUSION. THREE ALARIS MODULES AND TWO SETS OF BLOOD TUBINGS FAILED TO WORK PROPERLY WITH THE "AIR-IN-LINE" ALARM, ALTHOUGH THERE WEREN'T BUBBLES APPARENT IN THE TUBING. DELAY OF INITIATING TRANSFUSION, BUT DID NOT NEGATIVELY IMPACT PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8646084 ↗MalfunctionApr 11, 2019Material Separation; Material Separation
IT WAS REPORTED THAT THE TUBING SET SEPARATED AT AN UNKNOWN PLACE DURING PATIENT USE.
Patient problems: No Information
MAUDE report 8503889 ↗MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE BLOOD TUBING SET LEAKED WHERE THE Y TUBING ENTERS INTO THE DRIP CHAMBER IN THE INFUSION CENTER.
Patient problems: No Information
MAUDE report 8501990 ↗MalfunctionFeb 20, 2019Fluid/Blood Leak; Fluid/Blood Leak
RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "BLOOD SEEMS TO CLOT AT Y SITE CONNECTION CAUSING THE TUBING TO LEAK." THE INFUSION HAD COMPLETED WHEN THE CLOT AND LEAKING AREA WAS NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8355678 ↗MalfunctionJan 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A GENERAL COMPLAINT WITH NO SPECIFIC DETAILS THAT THE TUBING LEAKED ONTO THE PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8271967 ↗MalfunctionJan 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A GENERAL COMPLAINT WITH NO SPECIFIC DETAILS THAT THE TUBING LEAKED ONTO THE PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8271682 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT BLOOD WAS LEAKING FROM THE NON-USED Y SPIKE FROM ABOVE THE CHAMBER WHILE CONNECTED TO A PATIENT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8215665 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY NOTICED A LEAK WHERE THE SPIKED TUBING MEETS THE DRIP CHAMBER WHILE CONNECTED TO A PATIENT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8215631 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY NOTICED BLOOD LEAKING WHERE THE UPPER TUBING MEETS THE DRIP CHAMBER WHILE CONNECTED TO A PATIENT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8215618 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY NOTICED THE TUBING LEAKED IMMEDIATELY BEFORE THE DRIP CHAMBER FILTER WHILE CONNECTED TO A PATIENT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8215445 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THEY NOTICED A LEAK IN THE TUBING WHILE CONNECTED TO A PATIENT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8215353 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY NOTICED A LEAK ABOVE THE FILTERED DRIP CHAMBER WHILE CONNECTED TO A PATIENT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8215323 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY PRIMED THE TUBING THEN 10 SECONDS LATER THEY NOTICED A LEAK WHERE THE SPIKED TUBING MEETS THE DRIP CHAMBER WHILE CONNECTED TO A PATIENT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8215198 ↗MalfunctionJan 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY NOTICED THAT AFTER PRIMING THE TUBING IS LEAKED FROM THE SECONDARY SPIKE ABOVE THE DRIP CHAMBER WHILE CONNECTED TO A PATIENT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8215040 ↗MalfunctionDec 26, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING SET LEAKED AT THE SILICONE PUMPING SEGMENT DURING USE ON A PEDIATRIC PATIENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8197985 ↗MalfunctionDec 18, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY NOTICED THE TUBING SET LEAKED BEFORE THE BLOOD REACHED THE CHAMBER WHILE CONNECTED TO A PATIENT IN THE PEDIATRIC DEPARTMENT. THERE WAS NO REPORT OF PATIENT HARM. DATE OF INCIDENT: A WEEK OR 2 AGO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8177178 ↗MalfunctionDec 18, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY NOTICED THE TUBING SET LEAKED BEFORE THE BLOOD REACHED THE CHAMBER WHILE CONNECTED TO A PATIENT IN THE PEDIATRIC DEPARTMENT. THERE WAS NO REPORT OF PATIENT HARM. DATE OF INCIDENT: A FEW MONTHS AGO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8177066 ↗MalfunctionDec 7, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT DURING A BLOOD TRANSFUSION IN THE PEDIATRIC CLINIC, THE SET SEPARATED ABOVE THE DRIP CHAMBER WHICH CAUSED BLOOD TO SPILL. THERE'S NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8143585 ↗MalfunctionDec 7, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WITHIN THE PAST 6 MONTHS, DURING A TRANSFUSION IN THE PEDIATRIC CLINIC, TUBING SEPARATED AT THE TOP OF THE DRIP CHAMBER AND LEAKED. THERE'S NO REPORT OF PATENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8143523 ↗MalfunctionNov 2, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING SET LEAKS AT THE SPIKE BECAUSE THE SLIDE CLAMPS ARE NOT VERY EFFECTIVE. WHEN USING ONE SPIKE AND THE OTHER ONE IS CLOSED IT STILL LEAKS FLUID OR POTENTIALLY BLOOD PRODUCTS ALL OVER. THE CLINICIAN NOTICED THE LEAKING ON THE FLOOR WHICH HAPPENED BEFORE THE PATIENT WAS IN THE OR ROOM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8034093 ↗
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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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