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

Catalog Number 8065751077

Device Problem Air/Gas in Device (4062)

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

Event Date 10/30/2020

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 system message appeared and bubbles continue to appear through the infusion line during surgical procedure.Procedure completed with no patient harm reported.

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 returned sample was visually inspected, and no obvious defects were found.The ball in the check valve of the drip chamber moved freely per specification.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.A calibrated console representing the current software version was used to test the sample.The light-emitting diode (led) rings on the console turned green as the probe connectors were engaged to the console, indicating the proper communication between the probe and the console.The sample could prime and pass intraocular pressure calibration successfully.The infusion pressure data was within specification.Toggling the infusion and the fluid/air exchange (f/ax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubble in various settings in all sub modes.The sample was able to pass all functional and performance testing.The sample met specifications.No system message code was generated, during testing.Fluid flowed from the balanced salt solution bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.The root cause of the customer's complaint could not be established.The returned sample functioned per specifications.After an 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.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.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: 10822650
• MDR Text Key: 217132454
• Report Number: 1644019-2020-00603
• Device Sequence Number: 1
• Product Code: LRO
• 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
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 8065751077
• Device Lot Number: 2342208H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1