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

Catalog Number	8065751618
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A nurse reported that the water was not coming out of the infusion pump before vitrectomy surgery.The surgery was completed after replacing the product with another one.There was no report of patient harm.
Additional 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.A used posterior pak was visually inspected and was tested using a system console.The sample primed and passed intraocular pressure (iop) calibration successfully.The sample was recognized as posterior cassette on the console.Fluid flowed from the balance salt solution (bss) bottle to the drain bag without any interfering.No air leak was detected from the infusion airline during priming process.No message code appeared on the screen.No leakage was detected 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.The infusion pressure rate was within specification.The pressure and flow rate was within specification.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 on, only air was introduced from the cassette to the infusion line.The root cause of the customer's complaint could not be established; the returned sample functioned per specification.This complaint has been reviewed and it is determined that no further actions will be pursed at this time as the sample met specifications.Based on our current tracking, there are no adverse trends for this reported complaint.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 PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18533387
• Report Number: 1644019-2024-00113
• Device Sequence Number: 15396953
• Product Code: LRO
• UDI-Device Identifier: 00380657516186
• UDI-Public: 00380657516186
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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 Expiration Date: 07/31/2025
• Device Catalogue Number: 8065751618
• Device Lot Number: 160VYA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown