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

Model Number	66021496
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Impaired Healing (2378); Skin Disorders (4543)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during npwt, the renasys go pump was alarming "blockage full".The renasys go canister 300ml had little to no drainage and crystals had released from solidifier pack into canister.The pump, the dressing, and the cannister were replaced, and the next day the alarm show off on the new renasys go pump.Patients wound sat in secretion and progress towards healing took a setback.Patient went to wound clinic and the npwt was discontinued.No other complications were reported.
Additional Manufacturer Narrative
H6: the device used in treatment was not returned for evaluation, with all information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause may include kinks, leaks in the vacuum circuit or a component failure.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported event.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.Instructions for use contains recommendations and precautionary statements for proper use of the product.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• 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
• MDR Report Key: 12389217
• Report Number: 8043484-2021-01704
• Device Sequence Number: 14346795
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 05000223491000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 66800914/RENASYS GO CANISTER 300ML
• Outcome Attributed to Adverse Event: Required Intervention