MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY

Model Number 66800697

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

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

Event Date 10/25/2013

Event Type  malfunction  

Event Description

Failure to alarm: the wound/burn nurse reported that dr.(b)(6) told her the foam was not compressed, did not feel compressed and did not alarm.

Manufacturer Narrative

Active investigation in-progress, results of the investigation will be provided in a supplement report.As a result of similar complaints smith & nephew has issued car02714 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.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 ez.

Manufacturer Narrative

No pictures or lot numbers information was provided for the soft port system investigation, therefore a visual or device history record review could be performed.The serial number for the renasys ez plus was provided and the device history record was reviewed, serial number (b)(4) was manufactured in accordance with the device master recorded, no discrepancy or rework noted.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 without additional clinical information for this event.The distributor inspection results showed that the device functioned according to operation test procedure both prior to after the reported event.Most probable cause may have been attributed to user technique during dressing application.Root cause for the failure to alarm is undetermined.However, 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.[comp (b)(4) ].

Event Description

Failure to alarm: the wound/burn nurse reported that dr.Told her the foam was not compressed, did not feel compressed and did not alarm.

• Brand Name: RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
• Type of Device: RENASYS EZ PLUS
• Manufacturer (Section D): 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: 3725264
• MDR Text Key: 4326930
• Report Number: 3006760724-2014-00063
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/03/2014

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?: Yes
• Device Operator: Nurse
• Device Model Number: 66800697
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/25/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/25/2013
• Initial Date FDA Received: 04/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1