MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 15CM X 20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802006

Device Problem Pumping Stopped (1503)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

It was reported that on the 2nd day of npwt utilizing a pico 7, it was noticed that all the indicator lamps had illuminated and the pump was not working.The treatment was continued with a backup pump.No patient harm.No delay was reported.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains further instances/ related events of the reported event.The device was used for treatment.The returned was evaluated.An initial visual inspection did not identify any issues.When fresh batteries were inserted, all indicator lights were solidly illuminated.This confirmed a relationship between the event and the device.Device performance data shows the device entered a non-recoverable error state due to a motor current error.The root cause was determined as a component failure.As the occurrence of this is within the acceptable range, 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.

• Brand Name: PICO 7 15CM X 20CM
• 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: 10859905
• MDR Text Key: 216846807
• Report Number: 8043484-2020-03930
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K180698
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802006
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1