Alaris, SmartSite 2478-0000Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Blood Set, 180 Micron Filter 2 Blunt Spikes Y-Site 253 cm (100 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885403235122), received between Aug 31, 2018 and Feb 26, 2020 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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.
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 Leak15
- Material Separation5
- Material Puncture/Hole3
- Break1
- Excess Flow or Over-Infusion1
Patient problems
- No Consequences Or Impact To Patient15
- No Known Impact Or Consequence To Patient2
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT DURING AN INFUSION, THE BLOOD INFUSED IN MINUTES INSTEAD OF ONE HOUR. THE BLOOD WAS PROGRAMED TO INFUSE AT A RATE OF 250ML/HR WITH VOLUME TO BE INFUSED (VTBI) OF 250 ML FOR A DURATION OF 1 HOUR. IT WAS FURTHER CONFIRMED DURING FOLLOW UP THAT PATIENT CARE WAS NOT DELAYED AND THAT THIS EVENT DID NOT CONTRIBUTE TO, OR RESULT IN A SERIOUS ADVERSE IMPACT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9760206 ↗MalfunctionNov 20, 2019Material Separation; Material Separation
IT WAS REPORTED THAT THE BLOOD TUBING SET SEPARATED FROM THE DRIP CHAMBER PRIOR TO SPIKING THE BAG OR IN USE ON A PATIENT. THE TUBING SET WAS NOT PULLED ON OR FORCED IN ANY WAY TO CAUSE THE TUBING TO SEPARATE FROM THE DRIP CHAMBER. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT OR STAFF MEMBER AS THERE WERE NO FLUID/MEDICATION IN THE TUBING SET WHEN IT SEPARATED AS THE EVENT OCCURRED PRIOR TO PATIENT USE, THEREFORE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9347310 ↗MalfunctionJun 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM FDA WHICH STATES, ¿DEFECTIVE BLOOD TRANSFUSION TUBING''. THE IV BLOOD SET LEAKED PACKED RED BLOOD CELLS FROM THE TOP OF THE FILTER. THE TUBING WAS CHANGED, THE TRANSFUSION WAS RESUMED, AND THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8723534 ↗MalfunctionMay 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A BLOOD TUBING LEAK. FIFTEEN MINUTES AFTER THE BLOOD TRANSFUSION WAS STARTED, A LEAK OCCURRED ABOVE THE DRIP CHAMBER AT THE CONNECTION OF THE TUBING RESULTING IN BLOOD DRIPPING DOWN ONTO THE IV PUMP AND FLOOR. THE TRANSFUSION WAS CONTINUED WITH A NEW BLOOD SET.
Patient problems: No Information
MAUDE report 8582652 ↗MalfunctionFeb 15, 2019Break
NEW IV TUBING PACKAGE WAS OPENED AND TUBING WAS FOUND TO BE BROKEN DIRECTLY ABOVE ONE OF THE PORT SITES. NO OBVIOUS RIPS OR TEARS - JUST SEPARATED. THIS WAS DISCOVERED BEFORE REACHING A PATIENT, AND NO HAZARDOUS SUBSTANCES WERE SPILLED AS THE RESULT OF THE TUBE BREAKING, HOWEVER THIS TUBING WOULD HAVE BEEN USED FOR CHEMOTHERAPY. THIS WILL BE RETURNED FOR FAILURE ANALYSIS. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, ALARIS, SMARTSITE (PER SITE REPORTER). THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8342871 ↗MalfunctionDec 7, 2018Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE BLOOD TUBING SET SEPARATED ABOVE THE FILTER AND Y-SITE PRIOR TO THE ADMINISTRATION OF BLOOD. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8140820 ↗MalfunctionDec 1, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHEN A PUMP WAS INFUSING BLOOD, THE SALINE TUBING SEPARATED FROM THE TOP OF THE FILTER THEN THE BLOOD LEAKED OUT OF THAT HOLE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8122085 ↗MalfunctionDec 1, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHEN A PUMP WAS INFUSING BLOOD, THE SALINE TUBING SEPARATED FROM THE TOP OF THE FILTERED DRIP CHAMBER OF THE BLOOD TUBING, WITH BLOOD LEAKAGE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8122073 ↗MalfunctionNov 12, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING SET LEAKED AROUND THE SPIKE DURING A PRBC INFUSION. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8060008 ↗MalfunctionNov 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT SHORTLY AFTER THE START OF A PLATELET TRANSFUSION, THE PLATELET LINE LEAKED AT THE ENTRANCE TO THE LONG FILTER CHAMBER. THE SET WAS PRIMED WITH NORMAL SALINE ON ONE SPIKE, IV PATENCY CONFIRMED, AND THE INFUSION WAS STARTED. THE NURSE THEN SPIKED THE PLATELET BAG AND STARTED TO PRIME THE TUBING SEGMENT LEADING TO THE FILTER CHAMBER. THE LEAK WAS OBSERVED AT THE TOP OF THE CHAMBER. NO PATIENT HARM WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8043528 ↗MalfunctionNov 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT SHORTLY AFTER THE START OF A PLATELET TRANSFUSION, THE PLATELET LINE LEAKED AT THE ENTRANCE TO THE LONG FILTER CHAMBER. THE SET WAS PRIMED WITH NORMAL SALINE ON ONE SPIKE, IV PATENCY CONFIRMED, AND THE INFUSION WAS STARTED. THE NURSE THEN SPIKED THE PLATELET BAG AND STARTED TO PRIME THAT TUBING SEGMENT LEADING TO THE FILTER CHAMBER. THE LEAK WAS OBSERVED AT THE TOP OF THE CHAMBER. NO PATIENT HARM WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8042956 ↗MalfunctionSep 20, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT IN THE PACU/OPERATING ROOM, THE SET WAS PRIMED WITH SALINE USING ONE OF THE SET'S SPIKES, WHEN THE OTHER SIDE OF THE Y-TUBING, (WHICH HAD NOT YET SPIKED THE BLOOD), CAME OFF. THIS OCCURRED WHILE THE SET WAS ATTACHED TO THE PATIENT, AND SALINE SPILLED. PATIENT HARM WAS NOT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7896145 ↗MalfunctionSep 7, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT AT THE START OF A BLOOD TRANSFUSION ON A PUMP, BLOOD BEGAN TO LEAK AROUND THE IV PUMP DOOR. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7856560 ↗MalfunctionSep 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PATIENT WAS TO RECEIVE ONE UNIT OF PRBC AND THAT SHORTLY AFTER THE INITIATION OF THE TRANSFUSION, THE BLOOD BEGAN TO BUBBLE OUT OF THE TOP OF THE DRIP CHAMBER. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7851359 ↗MalfunctionSep 5, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE CUSTOMER REPORTED PINHOLES WITH LEAKING IN THE 3 INFUSION SETS THAT WERE USED SEQUENTIALLY ON A PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7848240 ↗MalfunctionSep 5, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT ON MULTIPLE OCCASIONS THERE WAS A LEAK WHICH OCCURRED AROUND THE EXTRA PORT WHEN THE BLOOD TUBING WAS PRIMED. THERE WAS NO SPECIFIC INFORMATION GIVEN FOR THE EVENTS. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7848237 ↗MalfunctionSep 5, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE CUSTOMER REPORTED PINHOLES WITH LEAKING IN THE 3 INFUSION SETS THAT WERE USED SEQUENTIALLY ON A PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7848153 ↗MalfunctionSep 5, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE CUSTOMER REPORTED PINHOLES WITH LEAKING IN THE 3 INFUSION SETS THAT WERE USED SEQUENTIALLY ON A PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7848145 ↗MalfunctionAug 31, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE RN INITIATED A BLOOD TRANSFUSION AT 4:35 P.M. AND NOTED THAT THE TUBING SET BEGAN TO LEAK AT THE TOP ENGAGEMENT OF THE IN-LINE FILTER. THERE WAS NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7840154 ↗
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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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