MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEM RENASYS G GAUZE DRESSING KITS WITH SOFT PORT; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number WD66800934

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem Purulent Discharge (1812)

Event Date 08/23/2013

Event Type  malfunction  

Event Description

Failure to alarm: the patient stated that the dressing had been leaking profusely since her discharge from hospital.When the dressing was removed there was large pooling of purulous fluid under the gauze which was not being drained into the canister.The device never alarmed once while the leak was happening.

Manufacturer Narrative

The complaint in inconclusive because the circumstance cannot be duplicated and no product was returned for evaluation.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 with exudate leaking out at the wound site is that there was a blockage in the system at the same time as a leak (potentially at one wound site only), 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.In response to failure to alarm 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.The dhr was reviewed and no issues were found during the manufacturing and/or release of the device.No other complaints have been received for this lot number.The ura has been reviewed and the harms associated with the events were deemed acceptable.Complaints will continue to be monitored.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.

• Brand Name: RENASYS G GAUZE DRESSING KITS WITH SOFT PORT
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): SMITH & NEPHEW WOUND MANAGEM; 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: 3757538
• MDR Text Key: 4465964
• Report Number: 3006760724-2014-00130
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K110647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2014

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: WD66800934
• Device Lot Number: 2013080857
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/23/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/23/2013
• Initial Date FDA Received: 04/17/2014
• 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