SMARTeZ Pump 481012Recalls & reported problems
Epic International(Thailand) Company Limited · SMARTeZ Pump 100-200-0.5h · Class 2
Quick summary
This SMARTeZ infusion pump is an elastomeric pump for IV infusions. The 26 reports describe pumps that would not infuse or flowed slowly, and pumps leaking at the filter or seams during filling, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 28859299101013), received between Sep 6, 2018 and Feb 19, 2019 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Failure to Infuse” (14 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Failure to Infuse14
- Leak/Splash6
- Fluid/Blood Leak2
- Crack1
- Detachment of Device or Device Component1
- Difficult to Open or Close1
- Infusion or Flow Problem1
- Material Rupture1
Patient problems
- No Known Impact Or Consequence To Patient23
- No Information2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2019Leak/Splash
SMARTEZ PUMP (SE0200 -100, LOT# S8E46) CONTAINING ERTAPENEM 1 GRAM IN 0.9% SODIUM CHLORIDE 100 ML LEAKING AT FILTER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350459 ↗MalfunctionFeb 19, 2019Infusion or Flow Problem
SLOW FLOW WITH VANCOMYCIN 2 G/NS 250 ML SMARTEZ {SE0175-250; LOT· S8H02} AND CEFTRIAXONE 2 G/NS 100ML SMARTEZ {SE0200-100; LOT S8D33): 100 ML, 200ML /HR AND SMARTEZ 250 ML, 175 ML/HR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350454 ↗MalfunctionFeb 19, 2019Failure to Infuse
SMARTEZ PUMP (SE0200-100, LOT# S8E46) CONTAINING DAPTOMYCIN350 MG IN 0.9% SODIUM CHLORIDE 100 ML WOULD NOT INFUSE. LINE FLUSHING WITHOUT PROBLEM. RN DISCONNECTED/ REFLUSHED / RECONNECTED AND THEN IT EVENTUALLY INFUSED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350448 ↗MalfunctionFeb 19, 2019Fluid/Blood Leak
THREE (3) SMARTEZ PUMPS (SE0200-100, LOT# S7N32) BEGAN LEAKING AT THE BOTTOM SHOULDER WHERE THE BLADDER MEETS THE BOTTOM RING, WHEN THE TECH STARTED FILLING WITH 0.9% SODIUM CHLORIDE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350435 ↗MalfunctionFeb 19, 2019Leak/Splash
THREE (3) SMARTEZ PUMPS (SE0200-100, LOT# S7N32) BEGAN LEAKING AT THE BOTTOM SHOULDER WHERE THE BLADDER MEETS THE BOTTOM RING, WHEN THE TECH STARTED FILLING WITH 0.9% SODIUM CHLORIDE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350433 ↗MalfunctionFeb 19, 2019Particulates
SMARTEZ PUMP (SE0200-100, LOT# S8D33) CONTAINING CEFAZOLIN 2 GRAM (BATCH RX# H938108 , MIX DATE (B)(6) 2018) IN 0.9% SODIUM CHLORIDE 100 ML HAD A PARTICULATE FLOATING IN SOLUTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350422 ↗MalfunctionFeb 19, 2019Failure to Infuse
SMARTEZPUMP (SE0200-100,LOT# S8E46) CONTAINING ERTAPENEM 1 GRAM IN 0.9% SODIUM CHLORIDE 100ML WOULD NOT INFUSE AFTER 20 MINUTES. PICC LINE FLUSHING WITHOUT PROBLEM. ED IS DRIPPING WHEN DISCONNECTED AND UNCLAMPED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350408 ↗MalfunctionFeb 19, 2019Failure to Infuse
SMARTEZ PUMP (SE0200-100, LOT# S8E46) CONTAINING DAPTOMYCIN 500MG IN 0.9% SODIUM CHLORIDE 100 ML WOULD NOT INFUSE AFTER 40 MINUTES. PATIENT LINE FLUSHING WITHOUT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350402 ↗MalfunctionFeb 19, 2019Fluid/Blood Leak
THREE (3) SMARTEZ PUMPS (SE0200-100, LOT# S7N32) BEGAN LEAKING AT THE BOTTOM SHOULDER WHERE THE BLADDER MEETS THE BOTTOM RING, WHEN THE TECH STARTED FILLING WITH 0.9% SODIUM CHLORIDE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350391 ↗MalfunctionJan 23, 2019Failure to Infuse
SMARTEZ PUMP SE0200-100, LOT # S8C58) CONTAINING ZOSYN 4.5 GRAMS IN 0.9% SODIUM CHLORIDE 100 MLS WOULD NOT INFUSE. PATIENT'S LINE FLUSHING NORMALLY AND LINE CONNECTED TIGHTLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272151 ↗MalfunctionJan 23, 2019Difficult to Open or Close
CLAMP ON SMARTEZ 100 ML. 200 "ML/ML" (MODEL# SE0200-100. LOT S8C58) FILLED WITH 0.9% SODIUM CHLORIDE 90 ML WOULD NOT CLOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272150 ↗MalfunctionJan 23, 2019Failure to Infuse
SMARTEZ PUMP (SE0200-100, LOT#S8C58) CONTAINING MEROPENEM 1 GRAM IN 0.09% SODIUM CHLORIDE 100ML WOULD NOT INFUSE. WHEN DISCONNECTED, IT WILL DRIP. TUBING CONNECTED TIGHTLY, LINE FLUSHING WELL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272149 ↗MalfunctionJan 23, 2019Leak/Splash
SMART EZ PUMP (SE0200-100, LOT# S8D34) CONTAINING ZOSYN 4.5 GRAMS IN 0.9% SODIUM CHLORIDE 100 ML IS LEAKING/SPRAYING AT THE FILTER SEAM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272147 ↗MalfunctionJan 23, 2019Failure to Infuse
FIVE SMARTEZ PUMPS (SE0200-100, S8C58) CONTAINING 3-ERTAPENEM 1 GRAM IN 0.9% SODIUM CHLORIDE 100 ML AND 2- DAPTOMYCIN 600 MG IN 0.9% SODIUM CHLORIDE 100 ML WOULD NOT INFUSE. PATIENT CONFIRMED LINE FLUSHING AND WORKING FINE WITH OTHER ED'S.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272145 ↗MalfunctionJan 23, 2019Failure to Infuse
SMARTEZ PUMP ((B)(4). LOT# S8C58) CONTAINING ZOSYN 4.5 GRAMS IN O 9% SODIUM CHLORIDE 100 MLS IS NOT INFUSING PT / RN IS HAVING TO TROUBLESHOOT BEFORE IT WILL WORK PROPERLY. PT LINE IF FLUSHING FINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272144 ↗MalfunctionJan 23, 2019Failure to Infuse
FIVE SMARTEZ PUMPS (SE0200-100, S8C58) CONTAINING 3-ERTAPENEM 1 GRAM IN 0.9% SODIUM CHLORIDE 100 ML AND 2- DAPTOMYCIN 600 MG IN 0.9% SODIUM CHLORIDE 100 ML WOULD NOT INFUSE. PATIENT CONFIRMED LINE FLUSHING AND WORKING FINE WITH OTHER ED'S.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272142 ↗MalfunctionJan 23, 2019Failure to Infuse
FIVE SMARTEZ PUMPS (B)(4), S8C58) CONTAINING 3-ERTAPENEM 1 GRAM IN 0.9% SODIUM CHLORIDE 100 ML AND 2- DAPTOMYCIN 600 MG IN 0.9% SODIUM CHLORIDE 100 ML WOULD NOT INFUSE. PATIENT CONFIRMED LINE FLUSHING AND WORKING FINE WITH OTHER ED'S.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272141 ↗MalfunctionJan 23, 2019Material Rupture; Detachment of Device or Device Component
AFTER TECHNICIAN FILLED SMARTEZ PUMP ((B)(4). LOT#S8E46) WITH DAPTOMYCIN 500 MG IN 0.9% SODIUM CHLORIDE 100 ML, THE ED BUSTED AND BOTTOM RING SEPARATED FROM RESERVOIR.
Patient problems: No Information
MAUDE report 8272097 ↗MalfunctionJan 23, 2019Failure to Infuse
FIVE SMARTEZ PUMPS ((B)(4), S8C58) CONTAINING 3-ERTAPENEM 1 GRAM IN 0.9% SODIUM CHLORIDE 100 ML AND 2- DAPTOMYCIN 600 MG IN 0.9% SODIUM CHLORIDE 100 ML WOULD NOT INFUSE. PATIENT CONFIRMED LINE FLUSHING AND WORKING FINE WITH OTHER ED'S.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272085 ↗MalfunctionJan 23, 2019Failure to Infuse
FIVE SMARTEZ PUMPS (SE0200-100, S8C58) CONTAINING 3-ERTAPENEM 1 GRAM IN 0.9% SODIUM CHLORIDE 100 ML AND 2- DAPTOMYCIN 600 MG IN 0.9% SODIUM CHLORIDE 100 ML WOULD NOT INFUSE. PATIENT CONFIRMED LINE FLUSHING AND WORKING FINE WITH OTHER ED'S.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272084 ↗MalfunctionDec 10, 2018Leak/Splash
SMARTEZ PUMP (SE0200-100. LOT# S8C58) CONTAINING CEFAZOLIN 2 GRAMS IN 0.9% SODIUM CHLORIDE 100 ML IS LEAKING AT THE BASE OF DEVICE.
Patient problems: No Information
MAUDE report 8147456 ↗MalfunctionDec 10, 2018Failure to Infuse
SMARTEZ 100 ML VOLUME, 200 ML / HR, FILLED WITH CEFTRIAXONE 2 GRAMS/0.9% SODIUM CHLORIDE 100 ML, WOULD NOT INFUSE THROUGH IV LINE, BUT WOULD DRIP WHEN DISCONNECTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8147452 ↗MalfunctionDec 10, 2018Failure to Infuse
THREE SMARTEZ PUMPS, (SE0200-100, LOT S8C39X2 AND S8C57) CONTAINING ERTAPENEM 1 GRAM/0.9 SODIUM CHLORIDE 100 ML WOULD NOT INFUSE. WHEN PATIENT CONNECTED THE EDS TO HIS EXTENSION AND OPENED THE CLAMP, THE MEDICATION DID NOT INFUSE, EVEN AFTER CONNECTED FOR 30 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8147446 ↗MalfunctionDec 10, 2018Failure to Infuse
THREE (3) SMARTEZ PUMPS, (MODEL#SE0200-100, LOT# S8C39) CONTAINING DAPTOMYCIN 650MG/0.9% SODIUM CHLORIDE 100 ML WOULD NOT INFUSE .100 ML,200 ML/HR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8147440 ↗MalfunctionDec 10, 2018Leak/Splash
TWO SMARTEZ PUMPS (MODEL# SE0200-100, LOT# S8E20) CONTAINING CEFEPIME 2 GRAMS / 0.9% , SODIUM CHLORIDE 100 ML LEAKED.100ML,200 ML/HR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8147437 ↗
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 L25915-500D1-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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.