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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Mediastinal Shift (2198)

Event Type  Injury  

Event Description

In the paper: "a survey of cardiac surgery infections with pico¿ negative pressure therapy in high-risk patients".The authors of the study reported a case of mediastinitis.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no part or lot numbers were provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history review found further instances of the reported event.The device was used in treatment.As no samples were returned, a product evaluation could not be carried out.Dressings should be changed around every 3 days but in some cases may be left in place for 7 days.If the adhesive integrity is compromised due to prolonged wear, the surgical site may be susceptible to external contamination.A clinical investigation concluded: the data provided is from, ¿a survey of cardiac surgery infections with pico.¿ the limited information provided did not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause of the reported mediastinitis and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.As the product code is unknown, a review of the device labelling could not be carried out.The associated risk file contains the reported event.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith + nephew 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: UNKN PICO
• 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: 10770500
• MDR Text Key: 214109789
• Report Number: 8043484-2020-03487
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 01/21/2021
• Patient Sequence Number: 1