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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065751058
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2022
Event Type  malfunction  
Event Description
A nurse reported the three-way valve position of the gas-liquid exchange pipe was leaking and the three-way valve position had been cracked before a vitrectomy procedure.The whole procedure was delayed for 15min.The product was replaced and the procedure was completed.There was no report of patient harm.
 
Manufacturer Narrative
A nurse reported the three-way valve position of the gas-liquid exchange pipe was leaking and the three-way valve position had been cracked before a vitrectomy procedure.The whole procedure was delayed for 15min.The product was replaced and the procedure was completed.There was no report of patient harm.The manufacturer internal reference number is: (b)(4).
 
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 customer reported that the infusion auto infusion valve (aiv) filter was leaking in their pak.The posterior pak was visually inspected.The infusion manifold was wet; the other components were unused.The top housing of the auto stopcock separated from the base due to an insufficient weld.The root cause of the customer's complaint was determined to be related to equipment not maintaining consistent control of the weld process.Contributing factors identified were training issues during production when performing the integrity squeeze check on the component to verify a good weld and when performing maintenance on the equipment.Action was taken to determine root cause and to take appropriate corrective actions for complaints of a similar nature.Quality assurance identified the likely contributors to be related to equipment end of life and will be replaced with a new system.Procedural enhancements were also implemented for better control of process during quality checks and for better training of personnel during production and equipment maintenance.Complaints are reviewed and monitored at regular intervals for adverse trends.No further action has been identified for this reported event.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).
 
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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
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 Key13770380
MDR Text Key287195195
Report Number1644019-2022-00196
Device Sequence Number1
Product Code LRO
UDI-Device Identifier00380657510580
UDI-Public00380657510580
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Followup
Report Date 07/14/2022
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
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Catalogue Number8065751058
Device Lot Number2503058H
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/15/2022
Supplement Dates Manufacturer Received06/30/2022
Supplement Dates FDA Received07/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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