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

Model Number 66800164

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

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

Event Date 02/20/2014

Event Type  malfunction  

Event Description

Failure to alarm: dressing appeared to have a leak but device not alarming.Reported delay in device alarm.No exudate in canister, no pooling at wound.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint was not confirmed.An evaluation of the pump was conducted on 13 march 2014, no anomalies or problems were noted, the pump passed all functional tests and found working within specifications.Since negative pressure wound therapy involves various elements, it is difficult to determine and assign an exact root cause for the issue reported, thus root cause for the reported issue is deemed undetermined.Historical review of complaints for lot # kguj120119 showed no prior issue.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, a partial blockage may have 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 more 1 (one) minute.This is supported by the comments provided stating the alarm did not go off on removal of dressing, however, leak alarm triggered after canister was disconnected from port.

Event Description

Dressing appeared to have a leak but device not alarming.Reported delay in device alarm.No exudate in canister, no pooling at wound.

• Brand Name: RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE
• Type of Device: RENASYS GO RENTAL 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: 3829586
• MDR Text Key: 4497626
• Report Number: 3006760724-2014-00365
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/20/2014
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1