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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 SE0175-250
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2018
Event Type  malfunction  
Event Description
Pt's husband reported 3 smartez pumps (se0175-250, lot # s8h11) containing vancomycin 750 mg in 0.9% sodium chloride 250 ml would not infuse the dose.Patient¿s picc line flushes easily and medication drips from the ed when opened, but not when connected to the picc.Verified that all clamps on the ed and the picc were open when attempting to infuse.
 
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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 VI 23666
MDR Report Key7929883
MDR Text Key122803162
Report NumberMW5080297
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 10/01/2018
3 Devices were Involved in the Event: 1   2   3  
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 NumberS8H11
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/02/2018
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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