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

Model Number 66021496

Device Problems False Alarm (1013); Defective Alarm (1014); Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the renasys go device failed the function check.Device gave blockage full alarm.No case was involved.

Manufacturer Narrative

H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Inappropriate device alarms and alarms that occur in the absence of a pump malfunction will not directly cause or contribute to serious injury or death, even in a clinical setting.Additional conditions must also exist (e.G.Surgical / treatment conditions; patient factors; the unavailability of back-up or alternate therapies for greater than 24 hours) before an injury could possibly occur, and even under those conditions, the risk of patient harm is low.This event is considered not reportable pursuant to 21 cfr part 803.

Manufacturer Narrative

H10 :the information received by the manufacturer has been updated and it was determined that this case does meet the threshold for reporting and is a reportable event.Device alarms are intended to inform the user when a device is not performing as intended so that immediate action may be taken to resolve the issue and continue treatment.If a malfunction occurs that results in a loss of negative pressure or over pressure scenario and it is not noticed by the user due to the lack of an alarm, it may lead to wound complications including maceration, wound deterioration/dehiscence, infection and/or excessive bleeding that necessitate medical intervention to prevent serious injury.This incident is considered reportable pursuant to 21 cfr part 803.Result of investigation: the device, intended for use in treatment, was returned for evaluation.A visual inspection reported no defects.The functional evaluation found that the device failed the blockage alarm test and "therapy stop- high vacuum" was displayed, establishing a relationship between the device and the reported event.The root cause was identified as a defective vacuum pump.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Event Description

It was reported that the renasys go device failed the function check.Device gave blockage full alarm.No case was involved.After functional evaluation it was found that the device failed the blockage alarm test and "therapy stop- high vacuum" was displayed.

• 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
• MDR Report Key: 11057519
• MDR Text Key: 223363422
• Report Number: 8043484-2020-04351
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 05000223491000
• Combination Product (y/n): N
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1