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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND CO., LTD.) SMARTEZ PUMP; PUMP, INFUSION, ELASTOMERIC
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EPIC INTERNATIONAL (THAILAND CO., LTD.) SMARTEZ PUMP; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Model Number SE0100-100
Device Problems Defective Device (2588); Gas/Air Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2018
Event Type  malfunction  
Event Description
Patient reports smartez pump (model#se0100-100, lot: s7k30) leaking at end tubing where tubing connects to picc.He felt moisture on his pants about 10 minutes after connecting and unclamping the pump.Patient stopped the infusion, disconnected and saved the defective pump and started a new pump which infused without incident.Patient brought leaky smartez to infusion center.Rn reports no obvious defects visible.Per rn, "pt said he is sure the connection was snug-said there was no difference in procedure from any other infusion and he checked to make sure it was connected correctly.".
 
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Brand Name
SMARTEZ PUMP
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
EPIC INTERNATIONAL (THAILAND CO., LTD.)
tasit
pluakdaeng, rayong 21140 TH
TH  21140 TH
MDR Report Key7658268
MDR Text Key113242649
Report NumberMW5078204
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 06/29/2018
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 NumberSE0100-100
Device Lot NumberS7K30
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/02/2018
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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