MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH DEVICE & POWER SUP; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801280

Device Problems Defective Alarm (1014); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Event Description

It was reported that a leak on the bandage didn't generate an alarm on the console.There was no discontinuation of treatment.The incident was resolved by changing the console to a backup device.There were no delays reported.

Manufacturer Narrative

H10.H3, h6: we have now completed the investigation for this complaint.A review of the device history showed that this unit passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest the device did not meet product specifications nor did it allege any product deficiencies.Complaint history for the reported failure has been reviewed and shown that in the previous four years there have been further instances.These instances are being monitored to determine if additional actions are required.The device, used in treatment, has not been returned for evaluation.Visual inspection and functional evaluation could not be performed.We have been unable to confirm a relationship between the event and the device or identify a root cause on this occasion.It is possible in certain situations that the device may not alarm due to the pressure sensor readings inside the pump still being within tolerance.This situation could occur when there is misalignment or a physical blockage at the softport to dressing interface.Suction failure can occur as a result of an insufficient seal on the dressing.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TOUCH DEVICE & POWER SUP
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9392638
• MDR Text Key: 168623919
• Report Number: 8043484-2019-00876
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1