MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN FLUID MANAGEMENT DEV; ARTHROSCOPE

Model Number 7211006

Device Problems Excess Flow or Over-Infusion (1311); Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1901

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that during surgery, the dyonics 25 pump and/or dyonics 25 tubing ran fluid continuously and did not sense back pressure.It filled the patients quad full of fluid.The surgeon was able to catch the issue and stop the pump.It is unknown if a back-up device was available and if a delay occurred.No patient complications occurred.

Manufacturer Narrative

Internal complaint reference (b)(4).H10, h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Without clinically relevant information for evaluation, the root cause of the reported events cannot be determined.Therefore, based on insufficient information, a thorough medical assessment could not be performed at this.Should any additional relevant clinical information be provided, this complaint would be re-assessed.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKN FLUID MANAGEMENT DEV
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13719868
• MDR Text Key: 286918511
• Report Number: 1643264-2022-00081
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010543592
• UDI-Public: 03596010543592
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/24/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2024
• Device Model Number: 7211006
• Device Catalogue Number: 7211006
• Device Lot Number: 50970392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 06/22/2022; 06/22/2022; 11/23/2022
• Supplement Dates FDA Received: 06/22/2022; 08/29/2022; 11/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other