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

Catalog Number UNKN05005402

Device Problem False Alarm (1013)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/23/2020

Event Type  Injury  

Event Description

It was reported that since the patient got the device numerous blockage full alarms were displayed and rotech exchanged devices and those warnings have subsided.A new device was delivered on 22oct2020 but when it was unplugged it immediately alarmed low vacuum and it powered off.Rotech is sending the patient a new power cord and stated that if the power cord is defective it may not be fully charging so can¿t get enough power to apply the suction needed, the nurse mentioned that she has been cutting the hole over the foam a little bigger lately.It was discussed that if the hole is cut too big it can also cause a low vacuum warning.She was not with the patient at the time of the call but all the trouble shooting steps were discussed which she said she has tried.The patient has a wet to dry dressing on currently per hcp orders and to replace with renasys go dressing as soon as new cord arrives.She also said rotech informed her if the cord does not fix the problem, she has to ordered a brand new device to switch it out again.It was decided at time of call, she will wait until the new cord arrives, and will redress at that moment cutting the hole smaller than she has been and see if the device will work correctly from there and if not she will contact rotech again to receive the replacement device that has been ordered.Therapy discontinued per hcp orders until the new cord arrives.This nurse is not sure if pc was submitted for the other devices that were switched out and does not have serial numbers for those devices and does not know how many devices have been exchanged.No further 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 device and reported event or determine a root cause.A probable root cause could be due to kinks, leaks in the vacuum circuit or a component failure.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm, however as no harm has been alleged then additional review is not required.No lot/serial number has been provided therefore a review is not possible.The complaint history found other related 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 DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10859487
• MDR Text Key: 216819619
• Report Number: 8043484-2020-03912
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05005402
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention