MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO., LTD. SMART EZ PUMP DISPOSABLE ELASTOMERIC INFUTION PUMP; PUMP, INFUSION, ELASTOMERIC

Device Problem Failure to Infuse (2340)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2020

Event Type  malfunction  

Event Description

Smart ez pump (5 fu) to infuse over 46 hours.Patient returned after 46 hours with pump noted not to be deflating/infusing.Patient did not receive all of the 5fu of medication as prescribed.Fda safety report id# (b)(4).

• Brand Name: SMART EZ PUMP DISPOSABLE ELASTOMERIC INFUTION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 10137935
• MDR Text Key: 194863291
• Report Number: MW5094918
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2020

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR