MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO SINGLE USE NPWT 10X30CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800952

Device Problem Pumping Problem (3016)

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

Event Date 02/04/2019

Event Type  malfunction  

Event Description

It was reported that during therapy the light on the pump was shining steadily green, not blinking.The pump did not alarm when the dressing was dispatched.No patient harm was reported.A back up device was available.

Manufacturer Narrative

We have now concluded our investigation into this complaint.As of today, no additional information or sample requested for this complaint has become available.Without further information we cannot progress our investigation or confirm the details supplied in this complaint.In the absence of additional information, our investigation remains inconclusive.At this time an exact root cause cannot be determined.If additional information becomes available in the future, this case will be reopened.A review of the associated batch manufacturing records was not possible due to lot number supplied being incorrect.A complaints history review was carried out for a three year period using the product number provided, there have been only four further complaints reported with issue.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 SINGLE USE NPWT 10X30CM
• 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: 8406495
• MDR Text Key: 138361716
• Report Number: 8043484-2019-00153
• 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: 04/22/2019

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: 66800952
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/10/2019
• Supplement Dates Manufacturer Received: 02/08/2019
• Supplement Dates FDA Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1