MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO NEGATIVE PRESSURE WOUND THERAPY; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800164

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

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

Event Date 09/26/2013

Event Type  malfunction  

Event Description

Failure to alarm: renasys go canister filled to the brim.  machine not registering that the canister was full.Pump not alarming.

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 go.On (b)(4) 2013, smith & nephew received the above product complaint for a severity of potential correctable injury.No lot number information was provided for evaluation on soft port dressing kit.The renasys go pump lot# kgua120989 was provided; dhr review indicated no discrepancies/rework on this device.Given the limited information provided, this report is deemed inconclusive.Since, the negative pressure therapy involves various elements within a system (i.E.Pump, canister, soft port etc.), it is difficult to determine and assign a definitive root cause of the complaint described.The soft port achieves negative pressure by drawing air through the aeration disk located distal to the wound site and close to the quick-click connector.Air flows on the top foam layer (aeration pathway) to the wound, exudate and admitted air is removed through the bottom layer (fluid handling pathway).When negative pressure is achieved, the soft port will appear ¿compressed¿ with a ¿raisin-like¿ texture.Regarding pump not alarming, possible root causes may include: system was drawing enough air through the quick-click connector.System was drawing enough air through the canister connection.System was drawing enough admitted air through the fluid handling pathway.Loose antimicrobial filter insertion; caused a minor air leak between pump and canister filter hose.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 GO NEGATIVE PRESSURE WOUND THERAPY
• 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: 3754062
• MDR Text Key: 18570253
• Report Number: 3006760724-2014-00109
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083375
• 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: 04/14/2014

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: Other
• Device Model Number: 66800164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2013
• Distributor Facility Aware Date: 10/03/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/03/2013
• Initial Date FDA Received: 04/16/2014
• 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