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

Model Number 66800799

Device Problem Device Alarm System (1012)

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

Event Date 05/30/2012

Event Type  malfunction  

Event Description

Failure to alarm: softport completely off the wound with no leak or blockage alarm.

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 soft port stand alone.Smith & nephew received the above reported complaint for failure to alarm.No samples, pictures or lot number information were provided or received for evaluation, therefore, a device history record review investigation could not be performed with the limited information provided.Since the negative pressure therapy involves various elements within a system, it is difficult to determine and assign a definitive root cause of the complaint described.Regarding pump not leak alarming, the alarm was not triggered after the soft port tubing was removed from the wound since the system sensed that negative pressure was still maintained and the leak rate was not significant enough in order for the system to trigger an alarm.It is possible that the fluid handling pathway in the soft port was partially blocked with blood clots/exudate.Regarding blockage alarms, the fluid handling pathway must be ¿fully¿ occluded and in this case, an alarm would be triggered within 3 minutes.Possible root causes for pump not triggering a blockage alarm may include that the system was drawing enough air through the clp, canister connection between pump and canister filter hose or antimicrobial filter.This issue has been confirmed, and based on prior complaints for similar issues car 2346 was initiated to further investigate the root causes for failures of this type, and identify any potential corrective actions.This complaint will be reopened and investigated if more information is received at a later date.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: 3764210
• MDR Text Key: 4468279
• Report Number: 3006760724-2014-00239
• 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: Nurse
• Device Model Number: 66800799
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/30/2012
• Event Location: Hospital
• Date Manufacturer Received: 05/30/2012
• 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