Alaris, SmartSite 2425-0500Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Ball Valve Back Check Valve, 2 Y-Sites 298 cm (117 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613203021395), received between Mar 29, 2019 and Aug 26, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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
Device problems
- Fluid/Blood Leak2
- Insufficient Flow or Under Infusion1
Patient problems
- No Code Available1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED TUBING LEAK.
Patient problems: No Information
MAUDE report 8931110 ↗MalfunctionMar 29, 2019Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Insufficient Flow or Under Infusion
CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "PATIENT BEGAN WITH CONTINUOUS CHEMO AT 1145 AT 5ML/HR. LINE FLUSHED AND BLOOD RETURN NOTED PRIOR TO CHEMO START. AT 12:15 RATE INCREASED TO 10 ML/HR. TWENTY MINS LATER, CHEMO PAUSED SECONDARY TO PATIENT CALLING OUT AND SAYING HIS "BED FEELS WET AND I HAVEN'T PEED". RN NOTED TUBING FELT WET AND WAS LEAKING AT LOWER Y-SITE CLOSEST TO THE PATIENT. CHEMO DISCONNECTED AND NEW TUBING PRIMED. DOCTOR TO BEDSIDE AT THIS TIME. DECIDED TO DO A 25ML REPLACEMENT BAG BY CHEMO RN, APRN & MD WHICH WILL BE HUNG AT THE END OF THIS REMAINING BAG." THE EVENT OCCURRED IN THE PATIENT'S ROOM AND THERE WAS NO PATIENT HARM.
Patient problems: No Code Available
MAUDE report 8467102 ↗
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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
- 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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