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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 Failure to Deliver (2338)
Patient Problem No Information (3190)
Event Date 12/12/2018
Event Type  malfunction  
Event Description
Smartez pump (se0200-100, lot# unknown) containing daptomycin 700 mg in 0.9% sodium chloride 100 ml would not infuse.Patient attempt to disconnect/reconnect in order to get pump to infuse.Finally infused.
 
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Brand Name
SMARTEZ ELASTOMERIC INFUSION PUMP
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
EPIC INTERNATIONAL (THAILAND) CO., LTD
MDR Report Key8175569
MDR Text Key130983071
Report NumberMW5082221
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
Was Device Available for Evaluation? No
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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