MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT UNKNOWN NPWT DRESSING KIT

Lot Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/18/2014

Event Type  malfunction  

Manufacturer Narrative

Active investigation in progress; results of investigation will be provided in supplement report.

Event Description

Soft port was failing when used with foam on heavily draining wounds with no leak or blockage alarms.

Manufacturer Narrative

The complaint is inconclusive since the circumstance cannot be duplicated and no product was returned for evaluation.Since negative pressure therapy involves various elements within a system (i.E.Pump, canister, suction port etc), it is difficult to determine a definitive root cause for the failure to alarm.In order to achieve negative pressure, an appropriate wound seal must be obtained.Per clinical guidelines, it is important that the hole in the transparent film be cut to 0.6cm and that the opening in the soft port is properly aligned with the opening in the transparent film to ensure a good seal.When negative pressure is achieved, the soft port and dressing will both appear ¿compressed¿ or with a ¿raisin-like¿ appearance.The most likely root cause for the failure to alarm is that the pump received enough of a flow rate of air to prevent a blockage alarm from sounding.In order for a blockage alarm to be triggered, the fluid handling pathway must be fully occluded and an alarm would have been be triggered within 3 minutes.The system was holding the negative pressure, as evidenced by the soft port being compressed, most likely as a result of the partial blockage and a leak not significant enough to trigger an alarm.A definitive root cause for the event cannot be determined.In response to failure to alarm complaints, smith & nephew has issued car02714 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.A device history record review could not be performed because no lot information was received.Complaints will continue to be monitored.

Event Description

Soft port was failing when used with foam on heavily draining wounds with no leak or blockage alarms.

• Brand Name: UNKNOWN NPWT DRESSING KIT
• Type of Device: UNKNOWN NPWT DRESSING KIT
• 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: 3688979
• MDR Text Key: 15952246
• Report Number: 3006760724-2014-00045
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2014

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?: Yes
• Device Operator: Other
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/20/2014
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1