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	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, they set up axius blower mister c-cb-1000 and couldn't regulate the flow with the thumb wheel.It always stayed at full flow.They replaced the full system with a new one.It wasn't used on the patient.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 10/02/2023.An investigation was conducted on 10/3/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.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 braided tubing was connected to a regulated source of co2, not exceeding 50 psi (344 kpa).Co2 gas was able to flow through the iv tubing and was visibly and audibly observed coming out of the atraumatic tip.The iv spike was connected to a bag of saline through the iv luer lock connection.The bag was placed in a pressure cuff and inflated to approximately 150 mmhg (20kpa).The pinch clamp was opened and saline was observed to come out of the atraumatic tip with normal flow and no blockages.The irrigation mist was observed to flow out of the tip as expected.The flow rate was able to adjusted using the flow volume controller with no physical difficulties.Based on the returned condition of the device, the reported failure "improper flow or infusion" was not confirmed.The lot # 96255721 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: 17431146
• Report Number: 2242352-2023-00619
• Device Sequence Number: 6780174
• Product Code: FQH
• UDI-Device Identifier: 00607567700741
• UDI-Public: 00607567700741
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: C-CB.-1000
• Device Catalogue Number: C-CB.-1000
• Device Lot Number: 96255721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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