MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS SOFT PORT STAND ALONE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800799

Device Problem Obstruction of Flow (2423)

Patient Problems Burn(s) (1757); Purulent Discharge (1812)

Event Date 03/25/2020

Event Type  Injury  

Event Description

It was reported that in the application of abdominal dressing to treat compartmental syndrome with viscera exposures the exudate caused dermatitis and a little burn occurred over the skin, because the liquid with acidic ph came into contact with the skin so the drainage was interrupted, causing a dressing change but there was an obstruction in the soft port obstruction and as a consequence there was dressing saturation.The problem was solved after removing the entire dressing kit up to the soft port.

Manufacturer Narrative

H3, h6: the device used in treatment was returned for evaluation.Photos and videos were provided for review.A relationship between the reported event and device could be established however a root cause could not be determined.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review was performed for the product and failure mode reported, there have been further instances.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain the reported failure/harm or event.A clinical/medical review was performed, and no further actions are required.Probable root cause maybe an obstruction.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

Manufacturer Narrative

H3, h6: the device used in treatment was not returned for evaluation.Photos and videos were provided for review.A relationship between the reported event and device could be established however a root cause could not be determined.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review was performed for the product and failure mode reported, there have been further instances.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain the reported failure/harm or event.A clinical/medical review was performed, and no further actions are required.Probable root cause maybe an obstruction.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: RENASYS SOFT PORT STAND ALONE
• 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: 10246822
• MDR Text Key: 197997681
• Report Number: 8043484-2020-01770
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 40565125558
• UDI-Public: 40565125558
• Combination Product (y/n): N
• PMA/PMN Number: K142979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800799
• Device Lot Number: 50767371
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention