MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 15CM X 15CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802005

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  Injury  

Event Description

It was reported that when npwt was started utilizing a pico 7, the dressing was not compressed and the leak indicator lamp flashed.Fixation strips were applied but the problem was not solved.The leakage stopped when a part of the soft tube was pressed with finger.Please confirm the attached reference image.An ointment was temporally applied on the wound, and npwt is supposed to be restarted as soon as a backup device will be available.No patient harm.No delay was reported.The sample will not be returned due to the contamination.

Manufacturer Narrative

H3, h6: we have now concluded our investigation into the reported complaint.As no batch/lot numbers have been provided, it has not been possible to carry out a device history review.A complaint history review, was performed for the product and event description, there have been similar instances reported in the past three years.Event occurred during patient treatment.The device used in treatment was not returned for evaluation, therefore no functional evaluation could not be carried out.We have not been able to establish a relationship between the reported event and the device.It has not been possible to establish the root cause of the issue.Probable root cause is incorrect application of dressing, connection of tubing to dressing or to pump.The dressings must be applied as per the ifu in order to achieve a seal, so that negative pressure can be maintained.As the leak light stopped when the tube was pressed with a finger, this suggests that the pump was working but the dressing had not been applied correctly.The users of the reported product are advised to consult the ifu, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including application and removal of dressings, connection of tubing and activation of pump.As the event reported did not allege a significant non-transient harm to the patient or user, no clinical review or risk management review are required.The investigation has been closed.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.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.B1.

• Brand Name: PICO 7 15CM X 15CM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11617740
• MDR Text Key: 243894041
• Report Number: 8043484-2021-00774
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K111170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1