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

Device Problem False Alarm (1013)

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

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that patient called in stating that the renasys go is alarming for blockage.She states that she has performed all the troubleshooting methods that were provided to her upon discharge.She states that she has milked the tubing as well as powering device down and back on again as well as changing out the canister.She has also assessed her dressing and reports no abnormalities associated with it.Quick click connector had been disengaged at which time it was noted that amber light showing blockage remained on.Dressing had been changed two days prior.Patient states that she had gone to emergency room for assessment of device at this time.No harm or injury reported and no additional information available.

Manufacturer Narrative

H3, h6: 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 reported event or determine a root cause.Probable root cause may include; kinks, leaks, blockages or component failure, the ifu offer further guidance.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 events.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.

• Brand Name: UNKN 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: 11096111
• MDR Text Key: 224411221
• Report Number: 8043484-2020-04405
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1