MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS GO CANISTER 300ML; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800914

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that canister is blocking the negative pressure coming from the device to the wound bed, the exudate is not passing from the wound bed to the canister.After a canister of the same batch had the same issue, a different canister batch was tried and no issue.This issue was identified during procedure and the procedure was completed with a canister of a different batch.The canister from the hospital was tested by s+n team with a different renasys go device, to test if the issue was with the device and not the canister, but the same issue of canister being blocked was seen.No harm or injury reported.

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 causes may be due to the reported blockage or a component failure.The ifu offers further guidance.The manufacturing records show no evidence that the product did not meet 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 GO CANISTER 300ML
• 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: 10871214
• MDR Text Key: 217289281
• Report Number: 8043484-2020-03942
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 40565125695
• UDI-Public: 40565125695
• Combination Product (y/n): N
• PMA/PMN Number: K152163
• 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: 07/01/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 66800914
• Device Lot Number: D1911919
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1