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

Catalog Number	66801281
Medical Device Problem Codes	Partial Blockage (1065); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that immediately after changing the dressing and resuming treatment, in the renasys touch device & power sup the message of blockage alarm was displayed on the screen.The problem was not solved by exchanging the canister.The procedure was completed, without delay, using a s+n back-up device.No patient injuries and no other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause may include kinks, leaks or blockages.The ifu offers further guidance.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TOUCH DEVICE & POWER SUP
• Common Device Name: 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: 11741320
• Report Number: 8043484-2021-00977
• Device Sequence Number: 19888655
• Product Code: OMP
• UDI-Device Identifier: 05000223494476
• UDI-Public: 5000223494476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 66801281
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1