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

Model Number	C-CB.-1000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw 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 preparation for a coronary artery bypass procedure, blower mister spike broke off when harvester went to spike the iv bag.A new device was used to perform the procedure without incident.There was no delay.There was no patient involvement.
Additional Manufacturer Narrative
Tw id# (b)(4).The device was returned to the factory for evaluation on 09/25/2024.An investigation was conducted on 10/09/2024.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact blower misted handle or intact tip of device.The spike of iv connector was observed to be detached from the device.It was returned for evaluation.There were no other visual defects observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "break" was confirmed.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.
Event or Problem Description
N/a.

• Brand Name: AXIUS BLOWER MISTER
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 20358813
• Report Number: 2242352-2024-0001094
• Device Sequence Number: 12793784
• Product Code: FQH
• UDI-Device Identifier: 00607567700741
• UDI-Public: (01)00607567700741(21)96255711(11)221215
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K101274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown