SMARTeZ Pump 480041Recalls & reported problems
Epic International(Thailand) Company Limited · SMARTeZ Pump 270-10-27h · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18859299100040), received between Mar 6, 2020 and Mar 6, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).
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.
Most reported problems
Device problems
- Excess Flow or Over-Infusion1
Patient problems
- Overdose1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2020Excess Flow or Over-Infusion
PATIENT REPORTED THAT SMARTEZ PUMP THAT SHOULD HAVE INFUSED OVER 24 HR COMPLETED IN ABOUT 12 HRS. MEDICATION DISPENSED IN THE 10ML/HR, 270ML FILL SMARTEZ PUMP. THE FACILITY RETRIEVED SEVEN PUMPS FROM THE PATIENT. ONE RAN FAST, THE REMAINING WERE RETRIEVED FOR QA. SEVEN DEVICES AVAILABLE FOR EVALUATION. (ALTHOUGH AWARENESS DATE WAS 1/11, COMPLETE INFORMATION WAS NOT AVAILABLE TIL 1/24).
Patient problems: Overdose
MAUDE report 9801646 ↗
Other Pump, Infusion, Elastomeric devices
- EASYPUMP 4540018-02B. Braun Medical Inc. · PUMP, INFUSION, ELASTOMERIC313 reports
- Halyard 13568Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC86 reports
- ON-Q* Pain Relief System with SELECT-A-FLOW 13472Avanos Medical, Inc. · Pump, infusion, elastomeric73 reports
- Halyard 13472Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC68 reports
- EASYPUMP 4540008-02B. Braun Medical Inc. · PUMP, INFUSION, ELASTOMERIC54 reports
- DOSI-FUSER L25915-500D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
- DOSI-FUSER L25915-600D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
- Halyard 13561Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC42 reports
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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