MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800697

Device Problems Device Alarm System (1012); Leak/Splash (1354)

Patient Problem Fluid Discharge (2686)

Event Date 06/22/2012

Event Type  malfunction  

Event Description

Failure to alarm: the negative pressure machine showed a good pressure but the dressing was saturated and leaking.The machine never alarmed.

Manufacturer Narrative

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.Smith & nephew received the above named product reported as a field complaint for adverse event.The complaint was not confirmed, as the device was not available for evaluation.This complaint involves an adverse event for a system connection, which showed good pressure at 125mm/hg, dressing was saturated and leaking, and an alarm didn¿t trigger even after the removal of the port pad from the wound site.The serial number was reported as unknown; hence, a device history record evaluation was not possible for the device.Since the negative pressure wound therapy involves various elements, it is difficult to determine and assign a definitive root cause for the issue reported within the complaint.A possible root cause for the pump not triggering an alarm may include: a blockage caused by clotting at the head of the soft port or gradual blockage/buildup of blood clots/exudate inside the soft port fluid handling pathway.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.If a 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 a pump not triggering a leak alarm after the soft port removed from the wound means that the system was holding the negative pressure probably as a result of the blockage and a leak not significant enough in order to trigger an alarm.It is recommended to return the device in order to rule out a pump malfunctioning, as the cause of the reported issue.No corrective action will be taken at this time, the pump is needed in order to rule out a pump malfunctioning.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 NEGATIVE PRESSURE WOUND THERAPY
• 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: 3764202
• MDR Text Key: 4420976
• Report Number: 3006760724-2014-00244
• 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: 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800697
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/22/2012
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/22/2012
• Initial Date FDA Received: 04/22/2014
• 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