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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO., LTD. SMARTEZ ELASTOMERIC INFUSION PUMP; PUMP, INFUSION, ELASTOMERIC

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EPIC INTERNATIONAL (THAILAND) CO., LTD. SMARTEZ ELASTOMERIC INFUSION PUMP; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Model Number SE0200-100
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2018
Event Type  malfunction  
Event Description
Smartez pump (se0200-100, lot # s8e46) containing ertapenem 1 gram in 0.9% sodium chloride 100 ml leaking at filter.
 
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Brand Name
SMARTEZ ELASTOMERIC INFUSION PUMP
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
EPIC INTERNATIONAL (THAILAND) CO., LTD.
144 research dr.
hampton VA 23666
MDR Report Key8174789
MDR Text Key131135090
Report NumberMW5082194
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSE0200-100
Device Lot NumberS8E46
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/17/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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