Alaris 10800176Recalls & reported problems
BD Switzerland Sàrl · PCA Administration Kit Reusable Monoject Plunger Rod, Kit Contents: Administration Set, Model 30883 with: Microbore Tubing, Anti-siphon Valve, Reusable Monoject Plunger Rod (Compatible with Monoject Syringe Barrel) 234 cm (92 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403234415), received between Oct 20, 2020 and Jun 17, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Free or Unrestricted Flow1
- Misconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2025Misconnection; Misconnection
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DISCONNECTED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. IT WAS REPORTED BY CUSTOMER THAT WE HAD ANOTHER ISSUE WITH THE TUBING. ATTEMPTED TO PRIME PCA FENTANYL TUBING AND THE END THAT CONNECT THE FENTANYL TO THE PCA SNAPPED IN HALF, OCCLUDING THE TIP OF THE FENTANYL SYRINGE FROM BEING ABLE TO CONNECT TO A NEW TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236636 ↗MalfunctionMar 19, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT PCA KIT ASV MICROBORE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 10800176. BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT THEY HAD ANOTHER ISSUE WITH THE PCA SET. VERBATIM: MDACC HAD ANOTHER ISSUE WITH THE BIFURCATED TUBING YESTERDAY. PER OUR CONVERSATION PLEASE PUT EYES ON THE ALARIS TUBING WHEN YOU ARE ON CAMPUS THIS WEEK. THE SPIN COLLAR CAME DISCONNECTED FROM TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11531149 ↗MalfunctionOct 20, 2020Leak/Splash; Free or Unrestricted Flow; Leak/Splash; Free or Unrestricted Flow
IT WAS REPORTED THAT PCA KIT ASV MICROBORE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10800176 BATCH NO: UNKNOWN IT WAS REPORTED THAT THERE WAS TWO LEAKING INCIDENCES WITH THE ALARIS PUMP TUBING. PER CUSTOMER EMAIL: WE EXPERIENCED (2) TWO SEPARATE LEAKING INCIDENCES WITH THE ALARIS PUMP TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10703561 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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