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	Device Handling Problem (3265)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during wound therapy, the patient experienced vein bleeding while using a renasys touch device.The device was used in exposed areas of the intestinal tract in spite of the instructions for use indicating it should not be applied in such circumstances.This adverse event was treated by performing hemostasis and by discontinuing npwt.Treatment with gauze was applied instead.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device was returned for evaluation.A visual and functional evaluation found no faults the device performed within expected parameters, confirming this event is not related to a device malfunction.A documentation review was conducted, historical data, has revealed no manufacturing related concerns or escalation in regard to this event type, and no open corrective actions.The manufacturing records contain no contributory factors that could have caused or contributed to the event which was released according to the final product specification.The associated risk files mitigate the event and further delineated within the instruction for use which contains warnings specifically advising against using this device in such circumstances.Medical review concluded, based on the information provided, this report is due to improper use of the device.The device was used in exposed areas of the intestinal tract despite its contraindication the instructions for use indicating it should not be applied in such circumstances.According to the report, the device was left in place for approximately four hours, and this adverse event was treated by performing hemostasis and discontinuing the npwt and an application of gauze.The impact to the patient beyond that which has already been reported cannot be confirmed no concluded.Should any additional relevant medical information be provided, this case would be re-assessed.As detailed in the medical review and the ifu the probable cause for the event is misuse.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends.

• 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
• 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 ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 14288763
• Report Number: 8043484-2022-00141
• Device Sequence Number: 13868082
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown