MAUDE Adverse Event Report: EPIC MEDICAL PTE LTD. SMART EZ PUMP; PUMP, INFUSION, ELASTOMERIC

Device Problems Deflation Problem (1149); Failure to Infuse (2340); Pumping Problem (3016)

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

Event Date 10/18/2019

Event Type  malfunction  

Event Description

Smart ez pump (5 fu) to infuse over 48 hours.Patient returned after 48 hours with pump noted not to be deflating/infusing.Pump appeared to be full indicating patient did not receive any of the 5fu of medication as prescribed.Fda safety report id (b)(4).

• Brand Name: SMART EZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC MEDICAL PTE LTD.
• MDR Report Key: 9260563
• MDR Text Key: 164839970
• Report Number: MW5090791
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR