MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7Y SINGLE USE NPWT SYSTEM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802031

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

Event Description

It was reported that the orange flashing light and no vacuum to the dressing.This device deficiency did not lead to any adverse event.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaints history review was carried out using the lot and part numbers provided, there was one other complaint reported with this issue in the past two years.It was reported that the leak indicator continued to flash and no negative pressure was provided from the pump.The returned pump was evaluated to help to identify if there were any problems with the pump and/or what could have caused the reason for the complaint.It was found that the device did enter a leak state repeatedly which would lead to the device pausing therapy and stopping delivery of negative pressure wound therapy for a short duration.This is consistent with the event description reported.Air leaks are potentially caused by: 1.Dressing not applied properly, without creases and fixation strips 2.Filter/port not adhered to dressing correctly 3.Connector not correctly fastened and secured to the pump 4.Tubing trapped, folded over/kinked causing a blockage 5.Dressing integrity has been compromised to rectify air leaks within the device the troubleshooting section of the ifu should be followed.We have been unable to identify what caused the device to repeatedly enter a leak state and therefore the root cause remains undetermined.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.B5 updated.

Event Description

It was reported device had the orange light flashing and there was no vacuum to the dressing.This device deficiency did not lead to any adverse event.Back up was available, but the dressing was removed until (b)(6).

• Brand Name: PICO 7Y SINGLE USE NPWT SYSTEM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 9516870
• MDR Text Key: 174182183
• Report Number: 8043484-2019-00947
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802031
• Device Lot Number: 1833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 11/27/2019; 01/16/2020
• Supplement Dates FDA Received: 12/24/2019; 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1