MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TCH DEVICE&POWER SPLY; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 66801280

Device Problem Device Emits Odor (1425)

Patient Problems Fistula (1862); Injury (2348); Fluid Discharge (2686)

Event Date 10/14/2020

Event Type  Injury  

Event Description

It was reported that a renasys touch device smelled very bad.When the technical service opened the pump to clean the filter noticed that there were larvae in the filter compartment.The doctor who prescribed the treatment was alerted to what was happening with the equipment and the therapy was immediately suspended because, in addition to being clinically contraindicated (what the doctor already knew - off-label use), this was damaging the machine.No harm or injury reported on patient.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.Additional information, including the supplied images, have been reviewed.We have established a relationship between the reported event and the device.The root cause was determined as instructions for use not followed.Our medical review concluded: based on the information provided by the sales rep, the doctor was aware the application of npwt on a patient with an unexplored enteric fistula was contraindicated and likely contributed to the presence of the larvae and faeces on the filter.Additionally, the four photos provided were reviewed and confirmed the presence reported larvae on the filters.The renasys touch ifu warns: ¿when treating enteric fistulas, do not place npwt dressing in direct contact with exposed bowel.Cover the wound bed, including fistula opening, with non-adherent gauze or with one layer of saline moistened gauze.During treatment the patient¿s fluid levels must be closely monitored¿.According to the report, once the doctor was notified of the three events related to the npwt, the therapy was suspended.Therefore, we are currently unable to rule out a procedural variance as the likely cause of the reported event.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.The associated risk files contain details relating to harm.However, no harm has been alleged.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TCH DEVICE&POWER SPLY
• 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: 10810324
• MDR Text Key: 215328461
• Report Number: 8043484-2020-03788
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00040565126586
• UDI-Public: 00040565126586
• Combination Product (y/n): N
• PMA/PMN Number: K153209
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66801280
• Device Catalogue Number: 66801280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention