MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH NON CONNECT 4TH ED DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802134

Device Problems Obstruction of Flow (2423); Suction Failure (4039)

Patient Problem Skin Disorders (4543)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

It was reported that, during npwt, after a few days a renasys touch non connect 4th ed device began to show an obstruction alarm.It was impossible to fix it, even the cure was repeated again and the steps to avoid obstructions were followed, but the machine still showed an obstruction alarm.The wound became macerated.Treatment was resumed, without any delay, with a back-up device.Current health status of the patient is ok.

Manufacturer Narrative

H6: updated codes.H10: additional information the device has not been returned for complaint evaluation.All supplied information has been reviewed and the complaint cannot be confirmed.Medical review concluded; we are currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.According to the report, the wound became macerated, however, no supporting documentation, treatment or photos of the reported maceration was provided.It is unknown if the ifu for the renasys touch non-connect 4th ed device was adhered to.The instruction for use warns; ¿a full canister incorrect pump orientation and pump/height relative to the wound can contribute to the loss of npwt and exudate accumulation within the wound, which could lead to maceration, infection, or unrecognized bleeding.¿based on the information provided, the treatment was completed with a back-up device without any delay.Since the patient¿s current health status has been reported as ok, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this complaint would be re-assessed.Complaint history has recorded previous occurrences of this nature, no manufacturing problems or historical actions have been observed.A documentation review has been conducted, confirming the device was released according to specifications.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Smith and nephew can confirm the device met manufacturing specifications upon release for distribution and continue to monitor for adverse trends relating to this product range.This investigation is now complete, confirming the event is not related to a manufacturing problem and that no corrective actions are deemed necessary.

• Brand Name: RENASYS TOUCH NON CONNECT 4TH ED DEVICE
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12966853
• MDR Text Key: 281972981
• Report Number: 8043484-2021-01995
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K181204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 02/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other