MAUDE Adverse Event Report: SMITH NEPHEW, INC. DYONICS FLUID MANAGEMENT SYSTEM; ARTHROSCOPE

Model Number 7211010

Device Problems Break (1069); Pressure Problem (3012)

Patient Problem Swelling/ Edema (4577)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

During a procedure today with dr.(b)(6) and dr.(b)(6) (right acl repair) the smith and nephew fluid pump malfunctioned.Rn noticed that pump pressure inadvertently increased to 105, upon noticing this surgeon was immediately notified and the pump was lowered to the proper pressure of 50.The surgeon noticed some edema in the patient's right knee.Upon arrival in the pacu the patient's edema was significantly decreased.The piece of equipment was removed from the or and tagged broken.Representative was notified regarding malfunction and will be in to verify issue.The pump was changed out for another, the cartridge was changed, bio-med and the vendor for the pump were called.There was nothing found to be not working appropriately with the pump.The vendors are on site most days to support any potential issues.This issue was discussed in our staff meeting to further educate and to make all staff aware to observe for any further concerns.

• Brand Name: DYONICS FLUID MANAGEMENT SYSTEM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 15292586
• MDR Text Key: 298571984
• Report Number: 15292586
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7211010
• Device Catalogue Number: 7211010
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/25/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6205 DA
• Patient Sex: Male