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U.S. Department of Health and Human Services

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

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EPIC INTERNATIONAL (THAILAND) CO., LTD. SMARTEZ PUMP; ELASTOMERIC PUMP Back to Search Results
Model Number 481012
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Based on the descriptions of the event by user facility, the device functions normally.The initial observation of no flow could be due to poor connection with connector used on patient site.
 
Event Description
Patient called after hours nurse line to report his ball was not infusing even after connected for over 30 minutes, following usual administration steps.Patient instructed to disconnect tubing from picc line to see if dripping, he confirmed it was.Patient instructed to flush line again to make sure it was freely following and then reconnect tubing and allow to infuse for at least another 30 minutes.Instructed to call back if it did not infuse.Smart ez pump ((b)(4)) containing ceftriaxone 2 grams in 0.9% sodium chloride 100 ml finally infused per oic nurse.
 
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Brand Name
SMARTEZ PUMP
Type of Device
ELASTOMERIC PUMP
Manufacturer (Section D)
EPIC INTERNATIONAL (THAILAND) CO., LTD.
hemaraj eastern seaboard indus
500/73 moo 2, tasit
pluakdaeng, rayong 21140
TH  21140
Manufacturer (Section G)
EPIC INTERNATIONAL (THAILAND) CO., LTD.
hemaraj eastern seaboard indus
500/73 moo 2, tasit
pluakdaeng, rayong 21140
TH   21140
Manufacturer Contact
david lennarz
registrar corp
144 research drive
hampton, va 23666 
7572240177
MDR Report Key8272148
MDR Text Key134095528
Report Number3012429465-2019-00037
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151650
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/17/2019
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 Health Professional
Device Model Number481012
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/03/2019
Initial Date FDA Received01/23/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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