DOSI-FUSER L25915-250D5-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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08436020760020), received between Mar 28, 2018 and Sep 24, 2018 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak5
- Excess Flow or Over-Infusion1
Patient problems
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak
USING LEVENTON PORTABLE DOSI-FUSER LV 5. 2 2. 1 ML FOR OUTPATIENT CHEMO PATIENTS. HAVE HAD 4 INCIDENTS OF THE CHEMO LEAKING AT THE CAPILLARY SENSOR (TAPED TO THE SKIN OF THE PATIENT), HAS LEAKED AND CAUSED THE CHEMO TO CRYSTALIZE OUTSIDE OF THE PATIENT'S BODY. CONTACTED THE DISTRIBUTOR, PULLED AND RETURNED ALL CATALOG OF PRODUCT CODE #250D5 WITH LOT #170101L (22 EACH) FOR QA BY MANUFACTURER. PORTABLE CHEMO PUMP USED IN HEMATOLOGY ONCOLOGY PRACTICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7901273 ↗MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak
USING LEVENTON PORTABLE DOSI-FUSER LV 5. 2 2. 1 ML FOR OUTPATIENT CHEMO PATIENTS. HAVE HAD 4 INCIDENTS OF THE CHEMO LEAKING AT THE CAPILLARY SENSOR (TAPED TO THE SKIN OF THE PATIENT), HAS LEAKED AND CAUSED THE CHEMO TO CRYSTALIZE OUTSIDE OF THE PATIENT'S BODY. CONTACTED THE DISTRIBUTOR, PULLED AND RETURNED ALL CATALOG OF PRODUCT CODE #250D5 WITH LOT #170101L (22 EACH) FOR QA BY MANUFACTURER. PORTABLE CHEMO PUMP USED IN HEMATOLOGY ONCOLOGY PRACTICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7901271 ↗MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak
USING LEVENTON PORTABLE DOSI-FUSER LV 5. 2 2. 1 ML FOR OUTPATIENT CHEMO PATIENTS. HAVE HAD 4 INCIDENTS OF THE CHEMO LEAKING AT THE CAPILLARY SENSOR (TAPED TO THE SKIN OF THE PATIENT), HAS LEAKED AND CAUSED THE CHEMO TO CRYSTALIZE OUTSIDE OF THE PATIENT'S BODY. CONTACTED THE DISTRIBUTOR, PULLED AND RETURNED ALL CATALOG OF PRODUCT CODE #250D5 WITH LOT #170101L (22 EACH) FOR QA BY MANUFACTURER. PORTABLE CHEMO PUMP USED IN HEMATOLOGY ONCOLOGY PRACTICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7901270 ↗MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak
USING LEVENTON PORTABLE DOSI-FUSER LV 5. 2 2. 1 ML FOR OUTPATIENT CHEMO PATIENTS. HAVE HAD 4 INCIDENTS OF THE CHEMO LEAKING AT THE CAPILLARY SENSOR (TAPED TO THE SKIN OF THE PATIENT), HAS LEAKED AND CAUSED THE CHEMO TO CRYSTALIZE OUTSIDE OF THE PATIENT'S BODY. CONTACTED THE DISTRIBUTOR, PULLED AND RETURNED ALL CATALOG OF PRODUCT CODE #250D5 WITH LOT #170101L (22 EACH) FOR QA BY MANUFACTURER. PORTABLE CHEMO PUMP USED IN HEMATOLOGY ONCOLOGY PRACTICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7901269 ↗MalfunctionMay 22, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
250 ML/5 DAY PUMP WAS FILLED WITH 148.8 ML AT 5FU AND 31.2 ML OF NS (NORMAL SALINE) FOR A TOTAL VOLUME OF 180 ML FOR APPROXIMATE 96 HOURS INFUSION TIME. PUMP CONNECTED MONDAY (B)(46) AT 09.30 AND SHOULD HAVE RUN OUT ON FRIDAY (B)(6) AT APPROXIMATELY 08.00; BUT PATIENT STATED IT WAS AT "ZERO" ON THURSDAY (B)(6) AT 17.00; APPROXIMATELY 15 HOURS EARLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7533137 ↗MalfunctionMar 28, 2018Fluid/Blood Leak; Fluid/Blood Leak
USING LEVENTON PORTABLE DOSI-FUSER LV 5. 2 2. 1 ML FOR OUTPATIENT CHEMO PATIENTS. HAVE HAD 4 INCIDENTS OF THE CHEMO LEAKING AT THE CAPILLARY SENSOR (TAPED TO THE SKIN OF THE PATIENT), HAS LEAKED AND CAUSED THE CHEMO TO CRYSTALIZE OUTSIDE OF THE PATIENT'S BODY. CONTACTED THE DISTRIBUTOR, PULLED AND RETURNED ALL CATALOG OF PRODUCT CODE #250D5 WITH LOT #170101L (22 EACH) FOR QA BY MANUFACTURER. PORTABLE CHEMO PUMP USED IN HEMATOLOGY ONCOLOGY PRACTICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7376692 ↗
Other Pump, Infusion, Elastomeric devices
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- 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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