MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE; RENASYS GO NPWT DEVICE

Model Number 66800164

Device Problems Device Alarm System (1012); Detachment Of Device Component (1104); Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problem Fluid Discharge (2686)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

Failure to alarm: renasys go in situ with flat drain kit.On arrival to patient, exudate leakage, dressing lifted and wet underneath - no alarm.On slow removal of dressing, the gauze was tightly compacted around the drain and beneath the film.I could not wait three minutes to detect when an alarm was triggered - but once the dressing was removed, the pump did alarm.So i assume it is a dressing obstruction rather than a pump failure.

Manufacturer Narrative

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

Manufacturer Narrative

This complaint is deemed inconclusive.An evaluation was not possible, device was not returned and no lot number information was provided, therefore, a root cause for the reported issue cannot be determined.Loss of dressing adhesion could be attributed to a combination of factors such as wound location, patient mobility, constant friction, pressure directly applied to wound site, accumulation of moisture underneath the dressing, and proper preparation of the periwound skin as per clinical guidelines.In regards to a pump not triggering a leak alarm, based on the complaint description, it is most likely that a partial blockage led to the observed issue.It is very likely the pump did not alarm because the system was still reaching vacuum in presence of partial blockage (potentially caused by clotting at the head of the soft port or gradual buildup of blood clots/exudate inside the soft port pathway) and/or a leak not significant enough to trigger an alarm.The system is designed to assert a leak alarm when the fluid has cleared the tubing set and air has been freely flowing through the tubing in a rate greater than 3.5l/min for more1(one) minute.This is supported by the complaint description which states the pump alarmed when dressing was removed.

Event Description

Renasys go in situ with flat drain kit.On arrival to patient, exudate leakage, dressing lifted and wet underneath - no alarm.On slow removal of dressing, the gauze was tightly compacted around the drain and beneath the film.I could not wait three minutes to detect when an alarm was triggered - but once the dressing was removed, the pump did alarm.So i assume it is a dressing obstruction rather than a pump failure.

• Brand Name: RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE
• Type of Device: RENASYS GO NPWT DEVICE
• 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: 3829563
• MDR Text Key: 4448194
• Report Number: 3006760724-2014-00363
• 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,Followup
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• 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
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/12/2014
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1