MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO V2 RENTAL

Model Number 66801244R

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

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

Event Date 01/06/2014

Event Type  malfunction  

Event Description

Failure to alarm: pump failed to alarm when dressing had completely fallen off.

Manufacturer Narrative

Additional investigation in-progress, results of the investigation will be provided in a supplement report.

Manufacturer Narrative

The reported complaint was not confirmed.A technical evaluation conducted at the (b)(4) service center on 21 may 2014 did not find any defect that could have contributed to the reported failure to alarm issue.The pump was found with cosmetic damages (broken top case), however, the pump passed all functional tests and found working within specification (refer to ra#208420-005).The root cause for the reported issue is deemed undetermined.Per information provided, the cited patient is very mobile, hoists himself in and out of bed/chair and drives a car.Based on this facts, loss of dressing adhesion could be attributed to a combination of factors such as wound location, patient mobility, constant friction and pressure directly applied to wound site.In regards to a pump not triggering a leak alarm, it can be hypothesized 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 or buildup of blood clots/exudate inside the wound filler (foam/gauze).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.Presence of partial blockage is supported by the fact that once dressing technique was changed to gauze with drain dressing stayed in place for much longer and pump alarmed when seal broke.Per the information provided no patient injuries or harm occurred in association with this issue.The complaint is recorded and any similar issues will be monitored through the complaint system.

Event Description

Failure to alarm: pump failed to alarm when dressing had completely fallen off.

• Brand Name: RENASYS GO V2 RENTAL
• Type of Device: RENASYS GO V2 RENTAL
• 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: 3646872
• MDR Text Key: 4201742
• Report Number: 3006760724-2014-00019
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/15/2014

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: Other
• Device Model Number: 66801244R
• Device Lot Number: KABH1130227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/06/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/06/2014
• Initial Date FDA Received: 02/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2014
• 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