MAUDE Adverse Event Report: SMITH AND NEPHEW WOUND MANAGEMENT RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800164

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913); No Pressure (2994)

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

Event Date 01/24/2012

Event Type  malfunction  

Event Description

Failure to alarm: we had three patients with serious wounds who had skin grafting done.The surgeon had ordered and applied negative ~ pressure wound therapy to minimize drainage remaining in contact with the grafted area.In all three cases the pumps did not alarm when there was no negative pressure applied.In at least two of the situations, the tubing was clamped and the pump did not alarm.

Manufacturer Narrative

The pump alarm settings are pre-determined and cannot be modified by health care professional.The renasys system provides blockage detection if there is a blockage to air flow suctioned into the pump from system connections that include at least a canister and the wound dressing.The pump by itself alarms to blockage/canister full if in the range of 0.0 l/min-0.05 l/min for which the pump motor operation drives the alarm electronically.For leak alarms, the leak rate exceeds the controlled leak rate in system connection.Alarms in system connections normally occur within a period of time in the range of 2-3 minutes, therefore not instantaneously.Smith & nephew has issued (b)(4) to initiate renasys product labeling updates.These labeling 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 GO NEGATIVE PRESSURE WOUND THERAPY DEVICE
• 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 ; 7273993785
• MDR Report Key: 3765982
• MDR Text Key: 4552746
• Report Number: 3006760724-2014-00284
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800164
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/06/2012
• Date Manufacturer Received: 02/06/2012
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1