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

Catalog Number	66020799
Medical Device Problem Codes	False Alarm (1013); Obstruction of Flow (2423)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during npwt a renasys go continues to alarm blockage/full canister, specifically on sundays.The wounds are filled with gauze.Patient has dressing changes and when she goes to he providers office on fridays the gauze which is packing the wound is filled with drainage and the wound continues to need debrided, patient states that they can see the edges of the wound are whit again and the wound is not healing.Patient is concerned that the pooling is preventing healing in addition to the blockage alarms.It is unknown how the therapy was finished; however, no delays were reported.No further information is available.
Additional Manufacturer Narrative
Internal reference number case (b)(4).
Event or Problem Description
It was reported that, following a hip surgery performed on (b)(6) 2023, a patient was initiated on npwt with a renasys go on three wounds all relatively together.The wounds were filled with gauze.The dressings are changed on mondays, wednesdays and fridays.On (b)(6) 2023, the patient notified the nurse that the dressing was getting saturated, so the patient went to the hospital for a wet-to-dry dressing change.On (b)(6) 2023, the patient has reported that, following fridays' visits to providers, the following sundays the pump displays the blockage / canister full alarm and that the gauze is filled with drainage.The device is always alarming blockage until patient milks the soft port.Also, the patient states that the edges of the wound are white again, and not healing, so is expressing the concern that the pooling is preventing healing.The doctor has already done two debridement procedures.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.Documentary review.A review of the complaint history has revealed a number of similar cases, there are no open or closed escalation actions for this combination of product and failure mode.A review of the device history record could not be conducted as no batch or lot number was supplied.The risk management documentation for the renasys dressings has been reviewed to assess whether the alleged failure and associated foreseeable harms have been anticipated.Risk documentation contains multiple failures leading to reduced npwt and reduced exudate removal resulting in maceration and delayed wound healing.The instruction for use provides adequate guidance, the ifu does warn, ¿inspect connections, tubing and soft port aeration disc (located on soft port, near the orange quick click connector) to ensure they are free of obstructions.Npwt devices are not designed to detect or issue an alarm condition based on the presence of bleeding or pooling.Medical review concluded based on the limited documentation provided, no clinical factors have been provided that would have contributed to the reported mechanical issues of the device.However, we cannot rule out the patient¿s history of diabetes as contributing factor to the reported impaired healing.It is unknown if the ifu for the renasys go device was adhered to.The impact to the patient was the fluid leaking, pooling, dressing changes, the wound debridement¿s and additional renasys go device.The future impact would include, dressing changes, the third debridement, office visits and continued npwt.Therefore, no further clinical/medical can be rendered at this time.The probable cause regarding the blockage is that the device has alarmed blockage as designed, the alarm was resolved by milking of the softport as detailed in the event description no manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.

• Brand Name: RENASYS GO
• Common Device Name: 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: 17857916
• Report Number: 8043484-2023-00066
• Device Sequence Number: 20315778
• Product Code: OMP
• UDI-Device Identifier: 00040565127248
• UDI-Public: 00040565127248
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 66020799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/18/2023; 03/04/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/10/2023; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female