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

Model Number 66021496

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Disorders (4543)

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, during npwt, the renasys go is displaying a warning blockage/canister full.The patient indicated that he underwent a dressing change and canister replacement.He also state that he had to stop using the renasys go for ten days due to the development of skin maceration; estimating the therapy discontinuation to be (b)(6) 2022.The wound is located on the patient's foot and is described as having a "tiny neck less than a 1cm opening and 3cm in length but with 1.5cm depth".The patient described the dressing as being firm and raisin-like in appearance.The patient was instructed to reset the device and disconnect at the quick click connector; both resulting in continuous therapy being re-stablished.The patient was encouraged to keep the device in an upright position as much as possible rather than allowing the device to lay on its back with its head raise slightly.The patient commented that he has never seen drainage in the tubing or the canister throughout his therapy use.Instead he reported that the dressing is often saturated upon changing.The patient noted that there was only one time where a "slight haziness of water" was noted in the tubing "but that only lasted one hour" per his account.The patient was encouraged to assure that upon dressing changing that the opening is cut to a quarter-sized diameter.The patient goes to a wound clinic twice a week for dressing changes and wound evaluation.The blockage/canister full warning did not appear throughout the entirety of the conversation with his nurse.No further information was provided.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, during npwt, the renasys go is displaying a warning blockage/canister full.The patient indicated that he underwent a dressing change and canister replacement.He also state that he had to stop using the renasys go for ten days due to the development of skin maceration; estimating the therapy discontinuation to be (b)(6) 2022.The wound is located on the patient's foot and is described as having a "tiny neck less than a 1cm opening and 3cm in length but with 1.5cm depth".The patient described the dressing as being firm and raisin-like in appearance.The patient was instructed to reset the device and disconnect at the quick click connector; both resulting in continuous therapy being re-stablished.The patient was encouraged to keep the device in an upright position as much as possible rather than allowing the device to lay on its back with its head raise slightly.The patient commented that he has never seen drainage in the tubing or the canister throughout his therapy use.Instead he reported that the dressing is often saturated upon changing.The patient noted that there was only one time where a "slight haziness of water" was noted in the tubing "but that only lasted one hour" per his account.The patient was encouraged to assure that upon dressing changing that the opening is cut to a quarter-sized diameter.The patient goes to a wound clinic twice a week for dressing changes and wound evaluation.The blockage/canister full warning did not appear throughout the entirety of the conversation with his nurse.No further information was provided.

Manufacturer Narrative

The device was not returned for evaluation.All supplied information has been reviewed and we have not been able to confirm the complaint.Medical review reports, this case reports maceration to the wound following the use of the renasys go device.The information provided is insufficient to determine whether the reported maceration is due to pre-existing or concurrent medical conditions or if the device was used for its therapeutic purpose as intended.The causal relationship between the renasys device and the reported issue cannot be confirmed.The renasys instruction for use (ifu) details the potential causes and remedies, and includes the following caution: ¿when monitoring patients for delivery of therapy, ensure wound dressing is free of air leaks, fully compressed and firm to the touch.¿ ¿carefully monitor the patient, device, and dressing frequently to determine if there are any signs of bleeding, exudate accumulation (pooling), infection, maceration, or loss of negative pressure wound therapy (npwt).A documentation review has been conducted, confirming previous complaints of this nature.No historical escalations or manufacturing problems were observed.A review of the device history confirmed that no manufacturing problems where observed.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.This investigation is now complete, with no manufacturing problems observed, no corrective actions are deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.

• Brand Name: RENASYS GO
• 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
• 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: 13577945
• MDR Text Key: 285941801
• Report Number: 8043484-2022-00076
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 05000223491000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention