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

Catalog Number 8065751767

Device Problem Fluid/Blood Leak (1250)

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

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 nurse reported water leaking from the cassette when priming.The product was replaced and the procedure was completed.There is 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.Water leakage from the cassette was reported.A turbid combined pak was visually inspected and no obvious defects were found.One white non-alcon stopcock was connected between the auto stopcock and infusion cannula line; the other was connected to the probe manifold.The ball in the drip chamber¿s check valve moved freely per specification.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.The 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.7500 cut rate displayed on the screen when the rfid was connected to the console.The submerge leak test was performed on the cassette.No leakage was observed.The sample was tested using a console.The sample failed to prime and generated a system message code 3471.After removing the non-alcon stopcock, the sample was tested again.The sample could prime, tune with the ultrasonic handpiece, the 0.9mm abs tip and infusion sleeve from the lab stock, and passed 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 drip chamber, the connectors, the cassette, the drain bag, the manifolds, 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 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.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: 11699436
• MDR Text Key: 246473024
• Report Number: 1644019-2021-00278
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657517671
• UDI-Public: 380657517671
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 8065751767
• Device Lot Number: 2427171H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1