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

Model Number 66800935

Device Problem Device Alarm System (1012)

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

Event Date 06/07/2012

Event Type  malfunction  

Event Description

Failure to alarm: dressing was not intact and no alarm on the ez plus.

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 g large w/soft port.Smith & nephew received the above reported complaint for failure to alarm.No samples, pictures or lot number information were provided or received for evaluation, therefore, a device history record review investigation could not be performed with the limited information provided.Since the negative pressure therapy involves various elements within a system, it is difficult to determine and assign a definitive root cause of the complaint described.Regarding dressing not intact (i.E.Hanging from patient), a reasonable explanation could be that the dressing became detached due to the patient¿s movement.The location of the wound/dressing is the sacral area and therefore, this could have proven to be challenging in maintaining a seal.Regarding pump not leak alarming, a probable cause could be attributed to the system sensing that negative pressure was still maintained and the leak rate was not significant enough in order for the system to trigger an alarm.This could be due to a partial blockage inside the soft port fluid handling pathway.In this case, a blockage alarm was not triggered.In order for a blockage alarm to be triggered, the fluid handling pathway must be ¿fully¿ occluded and an alarm would be triggered within 3 minutes.Possible root causes for pump not triggering a blockage alarm may include that the system was drawing enough air through the canister connection between pump and canister filter hose.(b)(4) was initiated to further investigate the root causes for failures of this type, and drive any potential corrective actions.This complaint will be reopened and investigated if more information is received at a later date.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: 3764222
• MDR Text Key: 4420975
• Report Number: 3006760724-2014-00251
• 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: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• 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: 06/07/2012
• Event Location: Hospital
• Date Manufacturer Received: 06/07/2012
• 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