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 Suction Failure (4039)

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

Event Date 06/02/2022

Event Type  Injury  

Event Description

It was reported that, during therapy on a large transverse abdominal wound, a renasys touch alarmed blockage/cannister full.Even though tubings, dressings and cannister have been checked, o-rings were cleaned and the patient was repositioned, the issue was not resolved.In addition, the patient's nurse stated that the wound was deepened during one of the weeks in which wound therapy was applied and the wound is 6cm deep x approximately 2-5 3tt.It is unknown if/how this adverse event was treated.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6.The device was returned for evaluation.A visual and functional assessment was performed.Material defects was noted, during testing a blockage full alarm was noted.A documentation review was performed.Historical review details previous cases reporting a false blockage alarm during use, which has triggered an adverse trend, resulting in corrective action.Corrective action has discounted the manufacturing batch records and process for both the canisters and the devices, as being contributory factors.Records confirm the devices have been manufactured and released according to the finished product specification.Risk files mitigate the reported event, delayed wound healing is potential harm.Which is delineated with the instruction for use, which details that when the reported alarm is displayed, this is to alert the user, therapy does not stop when blockage or full canister is displayed, therapy stops when the user pauses the device.A medical review was performed.We are currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.The renasys touch user manual details, ¿its use is contraindicated in the presence of untreated osteomyelitis, exposed arteries/veins/organs/nerves, necrotic tissue with eschar present, malignancy in the wound, non-enteric and unexplored fistulas and exposed anastomotic sites.Based on the information provided, it is unknown how this adverse event was treated.Therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed the root cause has been determined to be the result of, inadequate software design, however it does not interfere with the intended purpose of the device or impact patient safety.The actions implemented, include a planned software update, to reduce the probability, of future occurrences of false blockage/canister full alarms.No further corrective actions are deemed necessary.

Manufacturer Narrative

H6: health effect - impact code: corrected.

• 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: 14741438
• MDR Text Key: 294487256
• Report Number: 8043484-2022-00176
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention