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); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 05/03/2013

Event Type  malfunction  

Event Description

Trouble with the patient's dressing lifting with no leak alarm triggering.

Manufacturer Narrative

No samples, pictures or lot number information were provided or received for evaluation, therefore, a dhr review investigation could not be performed with the limited information provided.The complaint indicates the dressing was exposed and no leak or blockage alarm triggered.Regarding the dressing detaching from patient, a reasonable explanation could be that the dressing became detached due to the location of the wound.In regards to the pump not alarming for leak, the pump operates normally for leak rates up to a range of 2.5 -3.5 l/min but is designed to alarm for an excessive leak for more than 3 minutes.There is no detail within the complaint for how long the dressing was detached from the wound.The system is designed to assert a leak alarm when the fluid has cleared the tubing set and air has been freely flowing through the tubing greater than 3.5l/min.It is possible that thickened exudate in the tubing caused an occlusion and therefore, the air flow will not exceed the range in order to assert a leak alarm.The system was holding the negative pressure most likely as a result of a partial blockage and a leak not significant enough in order to trigger an alarm.Based on prior complaints for similar issues the soft port orifice size was increased to match the shape of the predicate port.The changes were incorporated in production during q2 2013 (reference (b)(4)).As a result of similar complaints smith & nephew has issued car02714 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.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: (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 soft port stand alone.

• 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: 3774113
• MDR Text Key: 4373706
• Report Number: 3006760724-2014-00335
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800799
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/03/2013
• Date Manufacturer Received: 05/03/2013
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1