MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS SOFT PORT STAND ALONE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800799

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

Patient Problem Fluid Discharge (2686)

Event Date 05/23/2012

Event Type  malfunction  

Event Description

Failure to alarm: found soft port not compressed with drainage leaking under the drape.The pump registered full suction at 120mmhg with no alarms.

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 soft port stand alone.No pictures, no samples and no lot number information were provided for evaluation.A device history record review investigation could not be initiated with the limited product information provided.Possible root causes for soft port not compressed with drainage leaking under the drape are: blockage caused by clotting at the head of the soft port with blood clots/exudate; gradual blockage/buildup of blood clots/exudate inside the soft port fluid handling pathway.The instructions for use (ifu) for renasys dressing kits with soft port indicate to maintain regular monitoring of the wound site during therapy to ensure therapeutic treatment and patient comfort.Also, the ifu includes that in the event of heavy drainage, more frequent dressing changes may be required.Analyzing all the possible elements, the pump did not alarm as the system sensed that somehow proper negative pressure was achieved and maintained, including the soft port.Possible root causes for pump not triggering a blockage alarm may include: system was drawing enough air through the quick-click connector, system was drawing enough air through the canister connection, system was drawing enough admitted air through the fluid handling pathway, loose antimicrobial filter insertion; caused a minor air leak between pump and canister filter hose, a combination of all of the above.Regarding pump not leak alarming, the leak alarm was not triggered after the soft port tubing was removed from the wound since the system sensed somehow that negative pressure was still maintained as a result of the blockage and the leak rate was not significant enough in order for the system to trigger an alarm.This issue has been confirmed, and (b)(4) was initiated to further investigate the root causes for failures of this type, and identify any potential corrective actions.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 SOFT PORT STAND ALONE
• 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 & 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: 3764191
• MDR Text Key: 4468745
• Report Number: 3006760724-2014-00240
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110647
• 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: 04/18/2014

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: Physician
• Device Model Number: 66800799
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/23/2012
• Event Location: Hospital
• Date Manufacturer Received: 05/23/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other