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

Model Number 66800799

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Impaired Healing (2378)

Event Date 05/28/2013

Event Type  No Answer Provided  

Event Description

Failure to alarm during pump rounds at the facility, i spoke to a nurse who mentioned her paraplegic patient had a dressing over a stage 4 pressure ulcer in the ischial area that was lifting with no leak alarm triggering.The nurse and wound care nurse attempted to reinforce the edges of the dressing that were lifting, but were having trouble maintaining a seal between dressing changes.The patient is incontinent and his stool was leaking into the dressing site and wound, preventing it from healing.

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.(b)(4).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 go npwt device.The complaint in inconclusive and no product was returned for evaluation.There was no lot information and so a production record review could not be performed.However, this is a known issue.Since negative pressure therapy involves various elements within a system (i.E.Pump, canister, suction port etc.), it is difficult to determine a definitive root cause for the failure to alarm.A leak alarm is designed to trigger if the system detects a significant leak.A potential cause of the pump not triggering a leak alarm is that there was a blockage in the system at the same time as a leak, resulting in the system being able to hold the required negative pressure.Also, in order for the leak alarm to sound, fluid must have cleared the tubing and a free flow of air must be detected for a specific amount of time.It is possible that there was exudate in the tubing that had not cleared and therefore the alarm did not sound.There is no indication from the complaint description that the pump was malfunctioning however this cannot be verified since the device was not returned for evaluation.A definitive root cause could not be determined at this time.The root cause of the weakened drape adhesion could not be definitively determined.The most likely root cause is either related to dressing application or dressing getting wet.The dhr could not be reviewed since no lot number was provided.In response to failure to alarm complaints, smith & nephew has issued a corrective action response (car 02714) 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.Complaints will continue to be monitored.(b)(4).

• Brand Name: RENASYS SOFT PORT STAND ALONE
• 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
• MDR Report Key: 3731395
• MDR Text Key: 4310522
• Report Number: 3006760724-2014-00066
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D126599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2014

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?: No
• Device Operator: Other
• Device Model Number: 66800799
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/29/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/29/2013
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1