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

Model Number	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	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw id# 888119.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.H3 other text : device not returned.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, blower mister co2 was blowing back into the saline back.They tried disconnecting and reconnecting the co2 but that didn't work.Opened up another device.About a 5 minute delay.No harm.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4) updated sections: b4, g4, g7, h2, h6, h10.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.The serial # (b)(6) 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: 17816352
• Report Number: 2242352-2023-00808
• Device Sequence Number: 11372581
• Product Code: FQH
• UDI-Device Identifier: 00607567700741
• UDI-Public: 00607567700741
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/01/2023

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: 03/31/2025
• Device Model Number: CB-1000
• Device Catalogue Number: CB-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown