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 Complaint, Ill-Defined (2331)

Event Date 06/22/2013

Event Type  malfunction  

Event Description

Failure to alarm pt with a guillotine amp with renasys ez plus/foam applied one day post-op, pressure 120mmhg.Approximately 24hrs after initial dressing application, staff nurse reported blood seeping out of dressing with a large coagulated collection of blood on the outside of the dressing, no alarm triggered.Foam was noted to only be partially compressed.Dressing was removed and a large amount of coagulated blood was noted at the base of the wound.Minimal bloody drainage was noted in the canister.Dressing was lifted with no audible alarm from the pump.Npwt was dc¿d at that time.No specific troubleshooting was done on the pumps at the time of the occurrence.

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: (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.This complaint was deemed inconclusive as the device was not returned for a technical evaluation after reporting this complaint.A complaint history review has not identified additional complaints against this device with serial number (b)(4).Review of the device safety checks performed at service provider shows the device was successfully inspected two days after the reported complaint occurrence date ((b)(6) 2013) per the inspection procedure and the equipment passed testing.The device was then returned to service until the time of the next inspection.The 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 order for the blockage alarm to be triggered, the fluid handling pathway must be ¿fully¿ occluded, if a ¿partial¿ blockage occurs at the wound site or within the fluid handling pathway and air still reaches the system, the pump will not alarm.In regards to the leak alarm, the system is designed to assert a leak alarm when the fluid has cleared the tubing set and air has been freely flowing through the tubing in a rate greater than 3.5l/min.The air flow will not exceed the range in order to assert a leak alarm.The system was holding the negative pressure most likely as a result of a partial blockage and a leak not significant enough in order to the alarm.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
• MDR Report Key: 3721617
• MDR Text Key: 4268843
• Report Number: 3006760724-2014-00049
• 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: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2013

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: 66800697
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/27/2013
• Initial Date Manufacturer Received: 06/27/2013
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1