Alaris 11612593Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 0.2 Micron Filter 285 cm (112 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403283963), received between Jul 13, 2018 and Jun 30, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 Leak4
- Leak/Splash1
- Material Puncture/Hole1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF GEM 20DP NO PORTS 0.2MF EXPERIENCED DEFECTIVE/DAMAGED TUBING CLAMPS AND LOOSE TUBING CLAMPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN RN OPENED THE PACKAGE FOR THE TUBING, THE CLAMP ROLLER FELL OUT. ON THE FLOOR. UPON CLOSER INSPECTION, THE TOP PIECE OF THE CLAMP WAS BROKEN, ALLOWING THE ROLLER TO FALL OUT CUSTOMER RESPONSE TO INFORMATION REQUEST 15 JUN 2020: ¿ WAS THERE ANY PATIENT INVOLVEMENT? NO. ¿ WAS ANYONE INJURED AND WERE ANY INTERVENTIONS NEEDED? NO.
Patient problems: No Patient Involvement
MAUDE report 10216200 ↗MalfunctionJul 13, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE CUSTOMER REPORTED THAT THE TUBING SET HAD A HOLE, AS WELL AS, THE FILTER WAS LEAKING DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7687399 ↗MalfunctionJul 13, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER WAS IN USE FOR LESS THAN 24 HOURS WHEN IT LEAKED WHILE INFUSING MAINTENANCE FLUIDS. THERE WAS NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7687031 ↗MalfunctionJul 13, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER LEAKED DURING A TPN INFUSION. THERE WAS NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7686977 ↗MalfunctionJul 13, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING LEAKED AT THE UPPER FITMENT DURING PATIENT USE AFTER 2 DAYS OF BEING IN USE. THERE WAS NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7686859 ↗
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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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