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 Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

Event Type  malfunction  

Event Description

It was reported that on the third day of the npwt utilizing a pico, the pump stopped working.The treatment was continued with a back-up device.No patient harm reported.

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.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.Our experts have provided a report of the analysis undertaken which confirms that ¿the device was tested and no anomalies was found¿ the pump had reached its 7 day expiry with a system time of 7 days, 8hrs.The eol (end of life) flag was reset and the pump functioned as expected with no issues detected.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.The 7 day timer is activated as soon as the batteries are inserted.As stated in the ifu ¿after 7 days of therapy the pump will automatically cease functioning¿ smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• 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 HU3 2 8N; UK HU3 28N
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 7567612
• MDR Text Key: 110033659
• Report Number: 8043484-2018-00125
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

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
• Device Lot Number: 1649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 05/07/2018
• Supplement Dates FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1