MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS 15 FR CHANNEL DRAIN A KIT; MESH, SURGICAL, POLYMERIC

Catalog Number 66801253

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 06/04/2020

Event Type  Injury  

Event Description

It was reported that the problem occurred only with the drainage kit and not the gauze drainage kit but the corresponding part number was given.During the course of the treatment in the anal area with canal drainage, both the touch pump and the go pump repeatedly displayed blockage alarms with the drainage.Due to the frequent alarm, the patient suffered from wound healing disorders and the findings worsened.This led to several additional operating theaters and a longer hospital stay.The problem lies on the t-vent of the drainage.

Manufacturer Narrative

H3, h6: the device, used in treatment, has not been returned for evaluation.Due to this we are unable to conduct a full assessment to establish a relationship between the event reported and the device or determine a root cause.If details are received in the future, then this complaint can be reassessed.As no batch/lot number has been provided it has not been possible to complete a review of the associated records.However, at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Complaint history for the reported event has been reviewed, revealing further instances.No relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.The associated risk files contain multiple failure modes that lead to blockage alarms occurring on renasys consoles.Failure modes include patient laying on the tubing, incorrect application of the dressing or an actual blockage which could lead to local infection, maceration and delayed wound healing.Without further information as to the nature of the adverse event or the cause of the blockage alarm, the failure mode or harm cannot be further narrowed down.A review of the instructions for use found adequate warnings, precautions and instructions on steps to be taken in relation to this event.Alarm thresholds are set after thorough testing and are always set to ensure the complete safety of the patient.It is possible in extreme cases that the alarm may trigger inadvertently.In this instance, therapy will still be delivered.The instructions for use offer further guidance with regards to false alarms.No further actions 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: RENASYS 15 FR CHANNEL DRAIN A KIT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10237902
• MDR Text Key: 197744355
• Report Number: 8043484-2020-01714
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K112784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 66801253
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention