MAUDE Adverse Event Report: SMITH AND NEPHEW WOUND MANAGEMENT RENASYS EZ PLUS; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800697

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

Patient Problem Fluid Discharge (2686)

Event Date 12/16/2011

Event Type  malfunction  

Event Description

Failure to alarm smith & nephew wound vac placed on patient.Dressing noted to have significant pooling of drainage under the drape.The pump did not alarm or identify any issue with the dressing or the inability to adequately pull away excessive drainage from the patient's wound.

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 ez plus.A pump malfunction was not confirmed as the device was not returned for evaluation.The root cause of the reported issue cannot be determined.A possible root cause is a blockage caused by clotting which may have occurred at the wound site.The renasys system provides blockage detection from the controlled leak path (the t-connector) to the canister.By design, the device will not alarm for blockage if the occlusion is below the t-connector (controlled leak path) on the wound side.The device is needed for investigation to rule out a possible device malfunction.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 EZ PLUS
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): SMITH AND NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH AND 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: 3765183
• MDR Text Key: 21494110
• Report Number: 3006760724-2014-00276
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2014

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: Other
• Device Model Number: 66800697
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/16/2011
• Date Manufacturer Received: 12/16/2011
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1