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

Model Number 66800697

Device Problems Device Alarm System (1012); Leak/Splash (1354); Device Operates Differently Than Expected (2913); Scratched Material (3020)

Patient Problem Discharge (2225)

Event Date 10/07/2013

Event Type  malfunction  

Event Description

Np went in to the room for dressing change.When patient was uncovered, np noted that on lower portion of open wound, the foam was exposed without transparent film covering and no alarm was sounding for leak.The wound was y connected to the upper wound which remained tight to suction.The area was very wet due to increase moisture from both area of the wound and size of the patient and surrounding skin folds.The film was pulled back and foam remained in wound.Upon inspection of the film, there was a large visible hole cut and could visualize that the entire open area of the back of soft port was in fact within that hole.Canister was plugged in to pump with filter fully engaged.Upon testing the pump the leak alarm did sound when troubleshooting with canister.Patient having serous draining no blood or clots within dressing, tubing, or canister.Pump was running at -200mmhg per md orders (common practice at this facility).Gel patch had been used but due to moisture in the area were nearly dissolved when dressing was removed.This same event occurred on dressing change the 2 days prior over the weekend.

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 ez plus.No lot numbers information was provided for the soft port or renasys ez pump and therefore no dhr review could be performed.The complaint was unconfirmed with the limited information provided.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 clinician indicated, there were high levels of exudate, and in accordance with the ifu the adhesive gel patch is indicated for use with low to moderate amount of drainage.The root cause of the complaint could not be determined.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 EZ PLUS 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 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: 3751973
• MDR Text Key: 4482199
• Report Number: 3006760724-2014-00090
• 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: Other
• Type of Report: Initial
• Report Date: 04/15/2014

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: Nurse
• Device Model Number: 66800697
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/07/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/07/2013
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other