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

Catalog Number 66802006

Device Problems Retraction Problem (1536); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/18/2020

Event Type  malfunction  

Event Description

It was reported that during treatment the device failed to make the vacuum, despite having applied both dressings of the kit correctly.No harm or injury reported and the device will not return.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, has not been received for evaluation.Visual inspection and functional evaluation could not be performed.We have been unable to establish a relationship between the device and the reported event or determine a root on this occasion.If this device is received, then complaint will be reassessed.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 has been reviewed with similar instances recorded in the past three years.A potential root cause for this problem is that there is an air leak with in the device.This can be caused for a number of reasons including: - dressing not applied properly, without creases and fixation strips - filter/port not adhered to dressing correctly - connector not correctly fastened and secured to the pump - tubing trapped, folded over/kinked causing a blockage - dressing integrity has been compromised - skin has not been thoroughly dried before application of the dressing causing the dressing to not sufficiently adhere to the skin users are advised to consult the ifu which details all steps to be taken in relation to the operation and use of the device.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + 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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10261946
• MDR Text Key: 199064249
• Report Number: 8043484-2020-01835
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2020
• 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: 201945
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention