MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH NON CONNECT 4TH ED DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802134

Device Problem Obstruction of Flow (2423)

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

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device stopped working at 3 a.M.While the patient was at home, and it displayed a blockage alarm.When the patient arrived at the hospital at 8 a.M.The machine was off and no possibility of starting.Currently the pump does not turn on.

Event Description

It was reported that the device stopped working at 3 a.M.While the patient was at home, and it displayed a blockage alarm.When the patient arrived at the hospital at 8 a.M.The machine was off and no possibility of starting.Currently the pump does not turn on.The issue was solved with a competitor's device.

Manufacturer Narrative

H3, h6: the device, was used in treatment was returned for evaluation.A visual inspection was performed and showed no damage to the device.Functional evaluation was performed and showed the device can´t start correctly, establishing a relationship between the event reported and the device.The root cause was determined as a defective mainboard.Our medical assessment concluded: per e-mail communication the patient was not harm due to the reported events.The treatment was continued with a different device.Since no patient injuries are being reported and no further harm is anticipated, no further clinical/medical assessment is warranted at this time.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event.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.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: RENASYS TOUCH NON CONNECT 4TH ED DEVICE
• 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: 11100869
• MDR Text Key: 224555406
• Report Number: 8043484-2020-04418
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K181204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 12/10/2020; 05/10/2021
• Supplement Dates FDA Received: 01/04/2021; 05/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention