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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; SMARTEZ PUMP

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EPIC INTERNATIONAL (THAILAND) CO., LTD. SMARTEZ ELASTOMERIC INFUSION PUMP; SMARTEZ PUMP Back to Search Results
Model Number SE0175-250
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2018
Event Type  malfunction  
Event Description
Smartez pump (se0175-250, lot# s8h02) containing vancomycin 1 gram in 0.9% sodium chloride 250 ml is taking 2-3 hours to infuse.Line is flushing good.
 
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Brand Name
SMARTEZ ELASTOMERIC INFUSION PUMP
Type of Device
SMARTEZ PUMP
Manufacturer (Section D)
EPIC INTERNATIONAL (THAILAND) CO., LTD.
MDR Report Key8160533
MDR Text Key130466083
Report NumberMW5082087
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 12/11/2018
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 NumberSE0175-250
Device Lot NumberS8H02
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/12/2018
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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