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); Leak/Splash (1354)

Patient Problem Fluid Discharge (2686)

Event Date 07/04/2012

Event Type  malfunction  

Event Description

Failure to alarm: not alarming leak despite exudate pouring from under the dressing.

Manufacturer Narrative

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 negative pressure wound therapy.The complaint was not confirmed, upon the evaluation of the returned device.Upon receivable of the device, all performance and safety check testing were conducted, as per "renasys go performance and safety check¿ obtaining acceptable results.The root cause is most likely due to circumstances unrelated to a malfunctioning of the device, usually related to the dressing method, kit or canister used.In the event there is a blockage at the wound site, as in a clot, the device may not alarm as the dressing may appear sealed to the device, resulting in continued exudate and leakage at the wound site.The pump is working within specifications.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: 3764209
• MDR Text Key: 4552742
• Report Number: 3006760724-2014-00234
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• 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: 04/17/2014

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: 66800164
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/04/2012
• Event Location: Hospital
• Date Manufacturer Received: 07/04/2012
• 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