MAUDE Adverse Event Report: SMITH AND NEPHEW WOUND MANAGEMENT RENASYS EZ PLUS; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800697

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/30/2013

Event Type  malfunction  

Event Description

Failure to alarm on (b)(6) 2013.(b)(6) was on routine rounds and heard that the pump had been beeping during the night.He took the initiative to swap out the pump and the issue resolved.When he tested the alarms the leak alarm failed.Later on (b)(6) 2013 the np changed the dressing again and instead of using a y connector he cut the aeration disc off of the soft port, removed the fluid handling pathway, assured foam touched foam and used npwt drape to connect it to the dressing.Stoma paste was used to minimize the leak from the jp drain under the drape.The dressing sealed and the pump was functioning normally.The patient was scheduled to be discharged later that day.".

Manufacturer Narrative

This medical device report (mdr) is being submitted by smith & nephew as a result of a retrospective review of complaints, including adverse events, as part of corrective and remediation actions following the issuance of the 483 issued november 26, 2013 to smith & nephew, inc.Fei no: 3006160724.Smith & nephew is performing a two-year retrospective review of complaint files to re-assess reportability criteria and reporting decisions made for complaints recorded during the time period under review.This complaint has been re-assessed in accordance under the provisions of 21cfr 803.50 and deemed reportable as an mdr.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the renasys ez plus.The compliant is confirmed.The return device concluded that the pump failed the high flow alarm test, noting a defective main pcb.The pump was submitted to (b)(4) for service and repairs.The pump main process control board (pcb), cases and clamp knob assembly were defective and replaced.The root cause of the event was attributed to the main pcb defective.The device was repaired, tested, and passed.Renasys ez plus pump go through a series of performance test and visual checks prior to release to market.Historical review of complaints for lot # kped120004 showed one prior issue with the hook clamp, non-related to this event.The reported complaint occurred during procedure and patient suffered no harm or deterioration of the wound or peri-wound skin.There was no delay in therapy in procedure due to this event.As a result of similar complaints smith & nephew has issued (b)(4) to initiate renasys product labeling updates.These labelling updates will provide enhanced information on the functionality of the alarms as they relate to the design of the device, and scenarios that can occur in clinical settings which may impact alarm functionality.

• Brand Name: RENASYS EZ PLUS
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): SMITH AND NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH AND NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 3754060
• MDR Text Key: 19294035
• Report Number: 3006760724-2014-00108
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• PMA/PMN Number: K102001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800697
• Device Catalogue Number: 66800697
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/05/2013
• Initial Date Manufacturer Received: 11/05/2013
• Initial Date FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1