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

Catalog Number	66021496
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a npwt treatment, the patient had two wounds in the abdomen, due to this, it was necessary to place two (2) renasys f small w/soft por connected with one (1) renasys y-connector, and these connected to one (1) renasys go.At the time of placement, apparently the renasys did not have enough suction capacity since it said there was leak.They placed the individual renasys go on each foam, and it sealed well, without leakage, but the same happened when both were placed simultaneously.They confirmed that the y connector did not have any leakage.As it continued giving the same error, they proceeded to leave only one foam in place.The next day there was no suction, and the patient's abdomen was a little swollen.The doctor proceeded to enter the patient into surgery to drain it.No delay or further complications were reported.The current health status of the patient is "stable".
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• Brand Name: RENASYS GO
• 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: 21351291
• Report Number: 8043484-2025-00007
• Device Sequence Number: 9079093
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 5000223491000
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K152163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/10/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RENASYS F SMALL W/SOFT PORT: 66020794, 2023060678.; RENASYS GO CANISTER 300ML: 66020914, D2129304.; RENASYS Y-CONNECTOR: 66020971, 51030451.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown