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U.S. Department of Health and Human Services

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

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EPIC INTERNATIONAL (THAILAND) CO., LTD. / REGISTRAR CORP. SMARTEZ ELASTOMERIC INFUSION PUMP; SMARTEZ PUMP Back to Search Results
Model Number SE0200-100
Device Problem Failure to Infuse (2340)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2018
Event Type  malfunction  
Event Description
Smart ez pump (se0200-100, lot# unknown) containing zosyn 4.5 grams in 0.9% sodium chloride 100 ml would not infuse.Patient tried to disconnect / reconnect 6 times, confirmed it was dripping each time.Patient then connected to the other extension tubing and it infused without problem.
 
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Brand Name
SMARTEZ ELASTOMERIC INFUSION PUMP
Type of Device
SMARTEZ PUMP
Manufacturer (Section D)
EPIC INTERNATIONAL (THAILAND) CO., LTD. / REGISTRAR CORP.
MDR Report Key8164532
MDR Text Key130617351
Report NumberMW5082119
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 12/12/2018
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 Received12/13/2018
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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