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

Catalog Number	66803126
Medical Device Problem Codes	Suction Problem (2170); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a renasys edge pump failed self test - leak and over vacuum cut off, was very loud and will not get a seal.No case involved; therefore, there was not patient involvement.
Additional Manufacturer Narrative
Section h10: the device was returned for evaluation.Visual inspection of the device found some minor wear to the display.A functional evaluation found that the device failed the self test when performing leak test and over vacuum test.A preliminary risk assessment ¿pra¿ was conducted.It was initiated following complaints for renasys edge failing self-test and noisy operation, the investigation recovered a number of the devices which were all inspected.The results concluded that black particulate matter from the carbon filter component of the renasys edge canisters has been confirmed to be entering the npwt pump and causing damage.It is suspected the dust filter between the carbon filter and the connection to the pump inlet is failing not sufficiently bonded.The pra was escalated to health hazard evaluation ¿hhe¿ to assess the risk to the user.The hhe concluded that in the most likely scenario, the canister and pump operate normally.There is no hazardous situation and no harm, and the health risk index is a ¿ none/negligible risk region.In the worst-case scenario, the canister filter fails during home healthcare use and pump stops functioning.The pump alerts the user to failure or leak alarm.There may be an extended delay in therapy while a replacement pump is sourced.This could potentially lead to wound deterioration or skin graft failure.The health risk index is b ¿ low risk region.Based on the potential for cumulative effects of the canisters on the pump function, the hhe conclusion is to advance to field action board ¿fab¿.The field action board initiated a product recall on both renasys edge 300 & 800ml canisters with solidifiers.The root cause of the failure was determined to be that carbon particles from the canister odour filter had passed through the dust filter into the pump unit of the device, which affects its ability to provide suction and can result in excess noise.Non-conformance ¿nc¿ was created to capture the investigation and plan changes with a corrective action currently in place to manage the actions needed to reduce the probability of future occurrences of this nature.Smith and nephew will continue to monitor for adverse trends relating to the reported allegation.S+n is conservatively reporting this event in association with a class ii recall of the concomitant canisters pursuant to applicable regulations.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: following a review of the available information, the manufacturer has determined that this event does not meet the criteria for mdr reporting.The device is intended to display an alarm/ alert if it detects an issue and may discontinue applying therapy until the issue is resolved.The loss of negative pressure wound therapy benefits would not be likely to cause or contribute to death or serious injury.Event may cause minor or temporary injury (e.G., delayed wound healing, maceration, etc.) requiring no or minor medical intervention.Event may require use of a backup device to continue therapy.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to applicable regulations.

• Brand Name: RENASYS EDGE PUMP
• 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
• 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: 19055021
• Report Number: 8043484-2024-00033
• Device Sequence Number: 8120462
• Product Code: OMP
• UDI-Device Identifier: 05000223498634
• UDI-Public: 05000223498634
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 66803126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 94248
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RENASYS EDGE CANISTER
• Patient Sex: Unknown