Alaris 30893Recalls & reported problems
BD Switzerland Sàrl · PCA SET EPIDURAL YELLOW 113 INCH · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403273964), received between Jul 25, 2018 and Dec 16, 2020 — classified as 4 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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Leak/Splash2
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT FOUR PCA SET EPIDURAL YELLOW 113 INCH EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 3 OF 3 MATERIAL NO: 30893 BATCH: 19025228 AND 18126639 I HAVE RECEIVED 4 REPORTS REGARDING LEAKING EPIDURAL TUBING OVER THE PAST 3 WEEKS. INITIALLY I THOUGHT IT WAS A ONE OFF OCCURRENCE BUT THAT DOES NOT SEEM TO BE THE CASE AFTER THE LAST EVENTS THAT WERE ENTERED OVER THE PAST COUPLE OF DAYS. SOUNDS LIKE IT'S COMING FROM MULTIPLE LOTS, THE ONLY LOT INFO I HAVE BEEN PROVIDED ARE LOT #¿S (10) 19025228 AND (10) 18126639. ON (B)(6) 2020 EPIDURAL TUBINGS KEEP LEAKING. WE HAVE TWO OF THEM HERE THAT LEAKED AT THE DISTAL END. PHARMACY SAID THEY TRIED 6 DIFFERENT ONES THAT ALL LEAKED, TRIED DIFFERENT LOT NUMBERS ETC. THEY FINALLY FOUND ONE THAT IS NOT LEAKING AT THIS TIME. PATIENT WENT FOR AN EXTENDED PERIOD OF TIME WITHOUT HIS EPIDURAL MEDICATION DUE TO THIS PROBLEM. PAIN TEAM MD IS AWARE. THE 2 TUBINGS WE HAVE ARE BEING SENT TO MATERIAL SERVICES. PHARMACY STATES THEIR MANAGEMENT IS ALSO AWARE OF THE PROBLEM. (B)(4), (B)(6) 2020 PT. ARRIVED FROM OPERATING ROOM WITH EPIDURAL IN PLACE, SYRINGE ON TUBING TO GIVE BOLUS DOSES BY ANESTHESIA AS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11023536 ↗MalfunctionAug 10, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT PCEA ASV YELLOW MICROBORE TUBING WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 30893-07 BATCH(LOT) NO: UNKNOWN. IT WAS REPORTED THE PCA BUTTON WAS PUSHED AND PARENT FELT WETNESS ON THEIR LEG. RN CHECKED TUBING AND NOTICED THE CRACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10384361 ↗MalfunctionAug 17, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT EPIDURAL TUBING LEAKED BELOW THE LUER LOCK ADAPTOR DURING AN INFUSION. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7794204 ↗MalfunctionJul 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT EPIDURAL TUBING LEAKED DURING INFUSION JUST BELOW THE LUER LOCK ADAPTOR. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7720246 ↗
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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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