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

Catalog Number	8065751902
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
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 cassette was leaking during surgery.The product was replaced and the surgery was completed.There is no patient harm.
Additional Manufacturer Narrative
Additional information provided in d.9, h.3, h.6 and h.10 the customer did not retain the product lot information for this constellation procedure pack, therefore the device history records traceable to the reported procedure pack could not be reviewed.The fms was reported to be leaking.A turbid 25+ga 5.0 cpm pak was visually inspected and no obvious defects were found.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.5000 cut rate displayed on the screen when the rfid was connected to the console.A submerge leak test was performed on the cassette.No leakage was observed.The sample was tested using a console.The sample could prime, tune with the ultrasonic handpiece, the 0.9mm abs tip and infusion sleeve from lab stock, and passed intra ocular pressure (iop) calibration successfully.Fluid flowed from the balanced salt solution 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
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11912136
• Report Number: 1644019-2021-00377
• Device Sequence Number: 3856533
• Product Code: LRO
• UDI-Device Identifier: 00380657519026
• UDI-Public: 00380657519026
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 08/31/2021
• Device Catalogue Number: 8065751902
• Device Lot Number: 2321278H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1