MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752452

Device Problems Pressure Problem (3012); Air/Gas in Device (4062)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available the manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that air bubbles appeared in the drain taking the fluid from the drip during a surgery.The system allowed air bubbles to pass through the infusion into the patient's eyeball.The pressure during the operation was unstable, which resulted in sudden increases and drops in fluid pressure during the procedure.Product replaced and procedure completed with no patient harm.

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The sample was visually inspected and no obvious defects were found.The sample was tested using the console.The sample could prime, tune with the ultrasonic handpiece, the 0.9mm air bubble suppressant (abs) tip and infusion sleeve from the lab stock, and pass intraocular pressure (iop) calibration successfully.Fluid flowed from the balanced salt solution (bss) bottle to the drain bag without any interfering.No air leak was detected from the infusion air line during priming process.No message code appeared on the screen.No leakage was found from the pump elastomer or onto the pump area of the fluidics module.The cleaning process was able to be performed after functional testing was completed.The sample passed functionality.With the infusion control on, fluid flowed from the cassette continuously without generating air to the infusion line.When the fluid/air exchange (f/ax) control was on, only air was introduced from the cassette to the infusion line.The pressure rate was within specification.The root cause of the customer's complaint could not be established as the returned fluidics management system cassette was evaluated and met specifications.After investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11506819
• MDR Text Key: 240615624
• Report Number: 1644019-2021-00165
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524525
• UDI-Public: 00380657524525
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 8065752452
• Device Lot Number: 2401494H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1