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

Catalog Number	66801281
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference: (b)(4).
Event or Problem Description
It was reported that, the patient died while using renasys touch.It was being used to treat a leg wound, 1500 ml of exudate was confirmed and the use of renasys touch was discontinued.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment was not returned for evaluation, all additional information provided has been reviewed and we have established a relationship between the reported event.The root cause has been determined as myocardial infarction.Medical review concluded, although this case reports the renasys touch wound therapy, was in use at the time of the patient¿s untimely demise, further information provided indicated the cause of the patient¿s death resulted from a myocardial infarction.Furthermore, there is no report or evidence that indicates the device contributory to this event.No further medical assessment is warranted at this time.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link, additional rmr is not required.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture, complaint history review found other related events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TOUCH DEVICE & POWER SUP
• 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: 11232702
• Report Number: 8043484-2021-00173
• Device Sequence Number: 19725512
• Product Code: OMP
• UDI-Device Identifier: 05000223494476
• UDI-Public: 5000223494476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 66801281
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 05/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR