MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO WITH SOFT PORT 15X15CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801361

Device Problem Pumping Problem (3016)

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

Event Date 05/13/2019

Event Type  malfunction  

Event Description

It was reported that customer contacted a sales rep to troubleshoot a pico pump.The lights were not working and neither was the pump delivering tnp.She had changed the batteries and all the lights flashed on and stayed on but the pump was still not working.The pump was put on patient new and died within 3 days.Would not turn on despite changing the batteries.Packaging was thrown out when first put on as there didn¿t appear to be any issues when it was first put on.The customer got another pump from the store.

Manufacturer Narrative

Our investigation into this complaint is now complete.A review of the associated batch manufacturing records was not possible due to no lot number being supplied.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.The analysis undertaken confirmed the device had failed due to liquid entering and flooding the internal electronic components.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.

• Brand Name: PICO WITH SOFT PORT 15X15CM
• 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: 8685513
• MDR Text Key: 147580690
• Report Number: 8043484-2019-00397
• 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: 06/30/2019

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: 66801361
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 06/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1