MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TCH 300ML CANISTER; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66801273
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during npwt utilizing renasys touch, the message of blockage alarm was displayed on the screen; the procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The device used in treatment has not been returned for evaluation, therefore we are unable to establish a relationship between the reported event, therefore the root cause is undetermined at this time.Alarm thresholds are set after thorough testing and are always set to ensure the complete safety of the patient.It is possible in extreme cases that the alarm may trigger inadvertently.In this instance therapy will still be delivered.Complaint history for the reported event has been reviewed, revealing further instances, these instances are being monitored to determine if additional actions are required.However, this investigation is now complete.As no batch/lot number has been provided a review of the device history has not been possible.However, at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Please be assured that all products are released to market following rigorous quality checks during production and prior to dispatch.

• Brand Name: RENASYS TCH 300ML CANISTER
• 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: 10770189
• Report Number: 8043484-2020-03481
• Device Sequence Number: 11044641
• Product Code: OMP
• UDI-Device Identifier: 00040565126524
• UDI-Public: 00040565126524
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66801273
• Device Catalogue Number: 66801273
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1