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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIC INTERNATIONAL SMART EZ ELASTOMERIC PUMP
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EPIC INTERNATIONAL SMART EZ ELASTOMERIC PUMP Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/24/2018
Event Type  No Answer Provided  
Event Description
Pt was to receive fluorouracil 3000mg/m2 dose (5850mg) as a continuous infusion over 96 hours via "270ml 5.5 day 2ml/hr smart ez elastomeric infusor." the pharmacy tech compounded the chemotherapy order using the wrong pump, instead selecting the "270ml 2 day 5ml/hr smartez elastomeric infusor." the verifying pharmacist did not catch the error.The nurse was administered the chemotherapy stated she noticed the product did not match that stated on the label, and she had a second nurse double check.Ultimately, they decided to proceed with administering the chemotherapy.The pt returned to clinic 2 days later for hydration and the pt / nurse noticed the pump was finished infusing.The pt received his chemotherapy too fast / the infusion finished infusing in approx 38.4 hours instead of 96 hours.(b)(6).
 
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Brand Name
SMART EZ ELASTOMERIC PUMP
Type of Device
SMART EZ ELASTOMERIC PUMP
Manufacturer (Section D)
EPIC INTERNATIONAL
MDR Report Key8674990
MDR Text Key147380429
Report NumberMW5087167
Device Sequence Number1
Product Code MEB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/25/2019
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? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
Patient Weight69
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