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

Model Number 66021496

Device Problem Pumping Stopped (1503)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 10/21/2021

Event Type  Injury  

Manufacturer Narrative

Reference number: (b)(4).

Event Description

It was reported that, during npwt, a renasys go displayed an alarm.Two weeks ago, patient had experienced it but was not aware so the machine stopped working for two days and ended in an infection.It is unknown how treatment was completed.Further information is not available.

Manufacturer Narrative

H3, h6: the device was not returned for complaint evaluation, all supplied information has been reviewed and we cannot confirm the reported event.As noted in the case report the patient was unaware that the device had stopped working.Without negative pressure being applied exudate can collect on the wound bed leading to infection.Medical review concluded; no relevant clinical medical information can be provided to conduct a thorough medical assessment.The patient's current condition is unknown.Should any additional clinical information be provided this complaint will be re-evaluated.A documentation review conducted confirming 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.Complaint history has recorded previous occurrences of this nature.Smith and nephew can confirm the device met manufacturing specifications upon release for distribution and continue to monitor for adverse trends relating to this product range.This investigation is now complete, confirming the event is not related to a manufacturing problem and that no corrective actions are deemed necessary.

• 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: 12787398
• MDR Text Key: 280585935
• Report Number: 8043484-2021-01948
• 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,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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