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

Model Number 66021496

Device Problem Suction Failure (4039)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint: (b)(4).

Event Description

It was reported that even thought stated continuous pression 120 mm hg the patient did not believe the device was working because it was not draining fluid.It was confirmed that the dressing looked compressed and the tubing was collapsed.Additional to this the patient reported experiencing a burning sensation in his leg and shooting pain in his foot while using the device so he was advised to contact the trauma center.Therapy was stopped until the patient receives further instructions from his doctor.The patient also stated that he believes that the nurse who placed his dressing may have not cit the hole big enough and it was not centered and that could have likely caused the draining problem.No further information is available.

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 cause may be application technique, dressing integrity has been compromised, or a component failure.The manufacturing records, show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found other related failures.The ifu has been reviewed.And contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain the reported failure/harm or event.However, the clinical review has not established a causal link.Additional rmr is not required.This investigation is now complete, with no further action deemed necessary at this stage.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Manufacturer Narrative

H3, h6: the device was returned for evaluation.All supplied information has been reviewed and we have not been able to confirm the complaint.Visual and functional evaluation was performed, with no faults found, the device performed within expected parameters.The instruction for use detail upon applying the soft port that an adequate opening is cut to allow for alignment of the soft port.Misalignment can affect the devices performance.Medical review concluded, the patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.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: 11071915
• MDR Text Key: 223593423
• Report Number: 8043484-2020-04377
• 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,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male