MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS SOFT PORT STAND ALONE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800799

Device Problem Device Alarm System (1012)

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

Event Date 05/07/2012

Event Type  malfunction  

Event Description

Failure to alarm: instances where the port had a leak at the base of the port where the channel extends.

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 soft port stand alone.Smith & nephew received the above product complaint for leakage issues.No pictures, no samples and no lot number information were provided for evaluation.A device history record/work order investigation could not be initiated with the limited information provided therefore; the complaint could not be confirmed.There are no specific details as to what exactly the observed failure was by the customer that caused the issue.Without samples or pictures for evaluation showing the defect experienced by the customer, it is very difficult to determine a definitive root cause with the limited information provided.The description indicates that the leak was ¿at the base of the port where the channel extends¿.It is unclear as to what the customer is referring to as ¿channels¿ in the soft port hear.Most probable is that these ¿channels¿ are the empty spaces that are created between the adhesive surface of the drape that is attached to the soft port head and the welded outside edges of the poly sheet of the device with the drape.This empty space runs on the periphery of the soft port head and is part of the design of the device, not a functional defect.The soft port design includes the control leak pathway (or clp) which admits air into the top layer of the soft port to be delivered to the wound site to allow for negative pressure to facilitate removal of fluids and exudate.The soft port is tested for leak test assembly and the specification is a leak rate of less than 0.015 liters per minute.If there is a leak that is within the specified limit, the system will not alarm.There is no indication of any risk or harm to the patient by the description provided.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 SOFT PORT STAND ALONE
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st petersburg FL 33716
• Manufacturer (Section G): SMITH & 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, FM 33716 ; 7273993785
• MDR Report Key: 3764207
• MDR Text Key: 19197821
• Report Number: 3006760724-2014-00247
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110647
• 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: 04/21/2014

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: Nurse
• Device Model Number: 66800799
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/07/2012
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/07/2012
• Initial Date FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other