MAUDE Adverse Event Report: EPIC MEDICAL PTE LTD. SMARTEZ DISPOSABLE ELASTOMERIC PUMP ; PUMP, INFUSION, ELASTOMERIC

Lot Number C8M58

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 01/15/2020

Event Type  malfunction  

Event Description

Pt sent home on (b)(6) 2020 from infusion clinic with smart-ez elastomeric pump filled with fluorouracil.Pt returned 6 hrs early on (b)(6) 2020 when he noticed pump was leaking.Nurse noted that pump connector was broken and piece was stuck to the luer lock.Male connector on pump may have cracked and caused pump to leak.Nurse cleaned white powdery material on skin around dressing site.(b)(4).Us.Fda saefty report id# (b)(4).

• Brand Name: SMARTEZ DISPOSABLE ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC MEDICAL PTE LTD.
• MDR Report Key: 9653383
• MDR Text Key: 177369093
• Report Number: MW5092645
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: C8M58
• Was Device Available for Evaluation?: No
• 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 Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 68