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

Model Number 66800059

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/14/2011

Event Type  malfunction  

Event Description

Failure to alarm: rn checked dressing on patient's left medial knee.Foam in wound found to be full of blood clots and new blood was dripping onto the floor with no occlusion or leak alarm from the wound vac.

Manufacturer Narrative

This issue was not confirmed as the device was not returned for investigation.The root cause of the reported issue cannot be determined.A possible root cause is a blockage caused by clotting which occurred at the wound site.The renasys system provides blockage detection from the controlled leak path (the t-connector) to the canister.By design, the device will not alarm for blockage if the occlusion is below the t-connector (controlled leak path) on the wound side.It is recommended that the device be returned for investigation to rule out a possible device malfunction.The renasys ez device has been replaced by the renasys ez plus, which has some new features and modifications.In addition, as a result of similar complaints smith & nephew has issued (b)(4) to initiate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.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 negative pressure wound therapy.

• Brand Name: RENASYS EZ 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 Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st petersburg, FL 33716 ; 7273993785
• MDR Report Key: 3765142
• MDR Text Key: 14879559
• Report Number: 3006760724-2014-00275
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082426
• 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: 04/21/2014

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: 66800059
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/29/2011
• Event Location: Hospital
• Date Manufacturer Received: 11/29/2011
• 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