DOSI-FUSER L25915-250D1-USARecalls & reported problems
Epic International(Thailand) Company Limited · Elastomeric Infusion Pump · Class 2
All models of DOSI-FUSER (5)
Data updated Oct 18, 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 08436020762178), received between Oct 5, 2018 and Oct 5, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
A WHITE POWDERY FILM WAS IDENTIFIED ON ALL THE PUMPS OPENED FOR 2 BOXES OF DOSI-FUSER 250D2 LOT 181171L. ALL CASES/PUMPS WERE SEQUESTERED AND RETURNED TO MANUFACTURER. IN ADDITION, THAT SAME WHITE SUBSTANCE WAS IDENTIFIED ON 2 DOSI-FUSER 250D1 PUMPS, LOT 181087L, THAT WERE RETURNED TO THE MANUFACTURER AS WELL. THIS WHITE POWDER IS OBSERVED BOTH IN THE INSIDE AND THE OUTSIDE OF THE TRANSPARENT CONTAINER.
Patient problems: No Patient Involvement
MAUDE report 7937876 ↗
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 L25915-600D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
- DOSI-FUSER L25915-500D1-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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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