MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS G LARGE W/SOFT PORT; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800935

Device Problems Device Alarm System (1012); Positioning Problem (3009)

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

Event Date 08/01/2013

Event Type  malfunction  

Event Description

Failure to alarm: prior to a dressing change noticed that a portion of a gauze dressing on the plantar portion of a patient¿s foot had slid down, exposing the wound bed.No leak or blockage alarm was triggered despite a portion of the wound bed being exposed.

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 g large w/soft port.Smith & nephew received the above named product reported as a field complaint for failure to seal / failure to alarm.The reported complaint is confirmed as a known issue even though no sample and/or photos were returned for evaluation.A device history record (dhr) review could not be performed because the lot number is unknown.The complaint indicates that the pump is not alarming even though the soft port was completely off of the wound site.Regarding the dressing detaching from patient, could be that the dressing became detached due to the location of the wound.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 lasting more than 3 minutes.Therefore, the alarm is not instantaneous.There is no detail within the complaint as to how long the soft port was detached.The system is designed to assert a leak alarm when the fluid has cleared the tubing set and air has been flowing freely through the tubing at a rate greater than 3.5l/min.It is possible that thickened exudate in the tubing caused an occlusion and therefore, the air flow would not exceed the range to trigger a leak alarm.The system was holding the negative pressure most likely as a result of a blockage and a leak not significant enough to trigger the 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 into production.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 G LARGE W/SOFT PORT
• 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: 3765987
• MDR Text Key: 4470674
• Report Number: 3006760724-2014-00287
• 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: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800935
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/01/2013
• Event Location: Hospital
• Date Manufacturer Received: 08/01/2013
• 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