MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC AXIUS BLOWER MISTER; LAVAGE, JET

Model Number	C-CB.-1000
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, blower mister was not blowing co2 well when they tested it before using it in the field.They kept saying this didn't feel like it was blowing.No kink and no connection issue.They opened a new device and it worked fine.No patient effects.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4) updated sections: b4, g4, g7, h2, h3, h6, h10 the device was returned to the factory for evaluation on (b)(6) 2023.An investigation was conducted on (b)(6) 2023.A visual inspection was conducted.Signs of clinical use and and no evidence of blood was observed.The flow volume controller was inspected and was observed to have no visual or physical defects.The controller was able to be rolled with no physical difficulties.The spike chamber was returned filled with saline.A microscopic evaluation was conducted.The flow path through the y-connector was observed to be clear.The glue connecting the shaft connecter and tubing was observed to be placed correctly.No occlusions caused by the glue were observed.The tip of the blower mister was observed to be intact with no visual defects observed.A functional test was performed.The returned iv spike and chamber was removed.A syringe was filled with water and connected to the saline port of the iv luer lock connection.The plunger of the syringe was depressed and water was observed to come out of the atraumatic tip with normal flow and no blockages.The braided tubing was connected to a co2 source, not exceeding 50 psi (344 kpa), and co2 gas was able to flow through the iv tubing.The sound of co2 gas was heard at the atraumatic tip while coming out of the tube.The syringe was depressed at a steady rate and the irrigation mist was observed to flow out of the tip as expected.Based on the returned condition of the device, the reported failure "improper flow or infusion" was not confirmed.The lot # 96255710 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: AXIUS BLOWER MISTER
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 16402504
• Report Number: 2242352-2023-00129
• Device Sequence Number: 3364962
• Product Code: FQH
• UDI-Device Identifier: 00607567700741
• UDI-Public: 00607567700741
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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: 10/31/2024
• Device Model Number: C-CB.-1000
• Device Catalogue Number: C-CB.-1000
• Device Lot Number: 96255710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male