MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC BLOWER MISTER, 5-PACK; 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	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw (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 using blower mister (cb-1000), when the co2 blower was used to perform vascular anastomosis, the blood should have been removed to secure a field of vision, but the blood was not removed and the co2 was not discharged.It was determined that this product was defective and a new product was used to perform the surgery.The newly used co2 blower product had no problems with removing blood or securing a field of vision during vascular anastomosis, so the surgery was completed successfully.There was a slight delay in the procedure.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Tw# (b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h6, h11.The lot # 96255756 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: BLOWER MISTER, 5-PACK
• 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: 21510869
• Report Number: 2242352-2025-0000228
• Device Sequence Number: 8007008
• Product Code: FQH
• UDI-Device Identifier: 00607567700741
• UDI-Public: (01)00607567700741(10)96255756(17)251130
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: 11/30/2025
• Device Model Number: CB-1000
• Device Catalogue Number: CB-1000
• Device Lot Number: 96255756
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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: UNKNOWN.
• Patient Sex: Unknown