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 Fluid/Blood Leak (1250)

Patient Problem Impaired Healing (2378)

Event Date 11/19/2023

Event Type  Injury  

Event Description

It was reported that, during npwt on (b)(6) 2023, it was noticed that one (1) renasys touch non connect 4th ed device was alarming warning leak.The device was turn off and turn on.During nightshift, staff changed dressing due to leak alarm, then, the device continued delivering therapy.On (b)(6) 2023, leak alarm sounds for am/pm.Nurses reinforced with hypafix dressing but device was still alarming.During night, dressing was changed, and the device continued working.It was noticed that there was no full graft on wound bed.On (b)(6) 2023, the doctor noted that the dressing had ben change from foam to gauze without plastic input and dressing should not have been touched without plastics input.The use of hypafix for rectifying leaks doesn¿t align with clinical guidelines.The treatment was resumed, without any delay, using a s+n back-up device.Patient returned to theatre for grafting of wound.

Manufacturer Narrative

Internal reference number: case-(b)(4).

• 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
• 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: 18315098
• MDR Text Key: 330327978
• Report Number: 8043484-2023-00091
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 66802134
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention