MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO NPWT DEVICE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800164

Device Problems Device Alarm System (1012); Leak/Splash (1354); No Pressure (2994)

Patient Problem No Information (3190)

Event Date 05/02/2013

Event Type  malfunction  

Event Description

Failure to alarm though there was exudate leaked from the dressing part, the alarm did not sound, and the pump took negative pressure continuously.

Manufacturer Narrative

An evaluation was conducted to the pump as per "renasys go performance and safety check¿ (rq-05 [(b)(4)], most current revision).A visual inspection was conducted and no anomalies were noted.The pump was tested per the normal test procedure for alarm functions and is working within specifications.A leak alarm will be trigger if the system detects a significant leak (>0.7 l/min for more than 1 minute).In regards to a pump not triggering a leak alarm with obvious drainage leaking out at the dressing site, most likely means that the system was holding the negative pressure, confirmed within the description of the report that the pump took negative pressure continuously, probably as a result of the blockage and a leak not significant enough in order to trigger an alarm.As a result of similar complaints 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.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the renasys go device.

• Brand Name: RENASYS GO NPWT DEVICE
• 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: 3774524
• MDR Text Key: 21452612
• Report Number: 3006760724-2014-00338
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800164
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/02/2013
• Date Manufacturer Received: 05/02/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1