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

Catalog Number	66803126
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for assessment, a visual and functional evaluation was performed.Inspection of the returned device confirms that the inlet port is heavily contaminated.The device event logs confirmed that this pump had failed the self test on numerous occasions for flow leak and over vacuum, in addition there was multiple fails for leak and performance related issue, this is a result of the heavy contamination found contained within the device.No further evaluation was necessary to confirm the event.A review of prior escalation actions has revealed that a preliminary risk assessment ¿pra¿ was conducted.The pra was initiated following complaints for renasys edge failing self-test and noisy operation, the investigation recovered and inspected several devices.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.An internal quality hold was also initiated.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, resulting in failed self-test, ability to provide suction and can result in excess noise.Non-conformance 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 monitor capa effectiveness and for further 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).
Event or Problem Description
It was reported that, during self-test one (1) renasys edge pump failed the flow test and the over vacuum cut-off test.As this was noticed in a non-surgical environment, there was no patient involved.
Additional Manufacturer Narrative
H10: 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: 20338666
• Report Number: 8043484-2024-00092
• Device Sequence Number: 7879838
• Product Code: OMP
• UDI-Device Identifier: 05000223498634
• UDI-Public: 05000223498634
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K223041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 09/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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