Alaris 10800177Recalls & reported problems
BD Switzerland Sàrl · PCEA KIT ASV YELLOW MICROBORE · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403234422), received between Aug 15, 2019 and Aug 15, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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 16, 2026.
Recalls naming this device
- Apr 9, 2020Terminated
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
Z-1968-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2019Fluid/Blood Leak; Fluid/Blood Leak
RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM FDA WHICH STATES, ¿INFUSING LEVOPHED DRIP PUDDLE NOTED ON FLOOR BY THE IV PUMP THE ACTUAL AMOUNT IN THE IV BAG SHOULD HAVE BEEN APPROXIMATELY 100 ML UPON DISCOVERY, ONLY 20 ML OF LEVOPHED LEFT IN THE IV BAG FLUID LEAKAGE FOR THE IV TUBING WAS LIKELY ABOVE WHERE THE TUBING IS INSERTED INTO THE IV PUMP THERE WAS NO HARM TO THE PATIENT." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. THE CUSTOMER STATES, "REVIEW OF THE MED WATCH DOCUMENT INDICATES THE DATE OF (B)(6) 2019 TIME IS 5:45 AM."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8898906 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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