MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO RENTAL DEVICE

Model Number 66800164R

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

Patient Problems Exposure to Body Fluids (1745); No Code Available (3191)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

Pump did not alarm when the dressing had failed and the patient was laid in exudate.

Manufacturer Narrative

Active investigation in progress, results of investigation will be submitted in a supplement report.In accordance with the provisions of 21cfr803.50, we are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a serious and unexpected adverse event which occurred while using a renasys go rental negative pressure wound therapy device.

Manufacturer Narrative

The reported complaint was not confirmed.A technical evaluation conducted at the (b)(4) service center on 14 march 2014 did not find any defect that could have contributed to the reported failure to alarm issue.The pump was found with cosmetic damages (broken top case and door flap), however, the pump passed all functional tests and found working within specification (refer to ra#203753-004).The root cause for the reported issue is deemed undetermined.Base on the information provided the patient was lying on her side, apparently over the wound site.No information was given on exact wound location, size, type of dressing application, pump placement, choice of wound filler, and pressure settings loss of dressing adhesion could be attributed to a combination of factors such as wound location, patient mobility, constant friction, pressure directly applied to wound site, accumulation of moisture underneath the dressing, and proper preparation of the periwound skin as per clinical guidelines.In regards to a pump not triggering a leak alarm, the most probable cause was that the system was maintaining negative pressure as a result of a partial blockage and a leak not significant enough in order to trigger an alarm.Typically, partial blockages are caused by clotting at the head of the soft port or buildup of blood clots/exudate inside the wound filler (foam/gauze) and/or the soft port fluid handling pathway.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.Per the information provide there were no patient injuries or harm associated with this issue.The complaint is recorded and any similar issues will be monitored through the complaint system.

Event Description

Pump did not alarm when the dressing had failed and the patient was laid in exudate.

• Brand Name: RENASYS GO RENTAL DEVICE
• Type of Device: RENASYS GO RENTAL DEVICE
• 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: 3677810
• MDR Text Key: 20716294
• Report Number: 3006760724-2014-00039
• 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,Followup
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 66800164R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/11/2014
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1