Alaris 10014917Recalls & reported problems
BD Switzerland Sàrl · Syringe Administration Set, Small Bore Tubing, Pressure Sensing Disc 152 cm (60 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403233937), received between Sep 28, 2018 and Mar 18, 2020 — classified as 1 injury, 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Insufficient Flow or Under Infusion1
Patient problems
- No Consequences Or Impact To Patient1
- Therapeutic Response, Decreased1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2020Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT DURING A MILRINONE INFUSION THERE WAS A LEAK AT THE MALE CONNECTION END OF THE SMALL BORE SYRINGE TUBING SET. THE NIGHT RN REPORTED THAT THERE WAS FLUID ON THE BED FROM THE LEAK, THEREFORE THIS WAS ALSO AN UNDER-INFUSION OF MEDICATION. THE SYRINGE TUBING SET AND SYRINGE WERE SWITCHED OUT WITH A LARGER BORE TUBING SET AND A NEW SYRINGE OF MILRINONE AND THE LEAK DID NOT REAPPEAR. THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9848087 ↗InjurySep 28, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING AN INFUSION OF MSO4 AT 0.37ML/HR, THE TUBING LEAKED AT THE FILTER. THE PATIENT NEEDED A PRN DOSE OF ATIVAN AS A RESULT. NO FURTHER ISSUES WERE REPORTED.
Patient problems: Therapeutic Response, Decreased
MAUDE report 7919802 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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