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

Model Number 66800799

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Device Slipped (1584)

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

Event Date 08/14/2012

Event Type  malfunction  

Event Description

Failure to alarm: care giver describes the event as the wound was pooling with secretions and the dressing was loose, leaking, and the pump did not alarm.

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 adverse event.No pictures or lot number information were provided, however, the soft port sample and associated materials used in patient were provided for evaluation.The sample was evaluated by s&n product development representative.During the evaluation, it was noticed that the wound dressing followed a non-standard (per instructions for use) application of materials.The complaint data collection sheet indicates that gauze was used as wound filler; however, a piece of foam (disc) was placed in between the holes in the drape layers.It was observed that: a pocket had formed between drape layers, there was no remaining tack to the drape layers; thus the foam appeared to be loose between the layers, soft port opening was blocked by the adjacent drape hole, drape material from the formed pocket could be moved with light force and would entirely occlude the soft port opening.Regarding pump not alarming, a renasys go device was attached to the returned materials to assess whether leak or blockage alarms were pending in their current state.On pump start, there was sufficient flow through the system to have a low vacuum alarm assert indicating leakage.Also, a blockage alarm was obtained by allowing the loose portion of drape to move and occlude the soft port opening.The complaint could not be confirmed.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 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, FL 33716 ; 7273993785
• MDR Report Key: 3756916
• MDR Text Key: 4486403
• Report Number: 3006760724-2014-00119
• 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: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• 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: 08/15/2012
• Event Location: Hospital
• Date Manufacturer Received: 08/15/2012
• 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