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

Catalog Number 051

Device Problem Pumping Problem (3016)

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

Event Date 02/13/2019

Event Type  malfunction  

Event Description

It was reported that the patient had a new pico pump at wound dressing change.The same day and when the patient was home, it went black and did no longer work.The patient looked after a possible leak and the pump was tried turned on and off, with no success.The patient came back to the surgical outpatient clinic the same day (in the afternoon) and a new pico was applied.Hcp also tried to check the pump when they received it from the patient, but without to manage that.No patient injury.

Manufacturer Narrative

Our investigation into this complaint has now concluded.The returned pump was passed to our in house experts so a thorough technical analysis could be carried out to help to identify if there were any problems with the pump and/or what could have caused the reason for the complaint.Our experts have provided a report of the analysis undertaken, this confirmed that the device was tested prior to being disassembled for assessment ¿ the device performed as expected without issue.No batteries were returned with the pump preventing assessment of the battery condition.A device history record review was carried out for the batch number supplied.This confirmed that the product had been manufactured in accordance with defined procedures and specifications and there was no record of any problems or deviations occurring during manufacturing of this product.Prior to manufacturing, all pico pumps undergo full functionality testing to an agreed specification.This ensures that all pumps are working correctly before being shipped to our customers; any failures identified are segregated for investigation.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products, however on this occasion no fault can be found with the returned device.

• Brand Name: PICO
• 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: 8410495
• MDR Text Key: 138506515
• Report Number: 8043484-2019-00167
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/05/2019

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: 051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR