MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC BLOWER MISTER, 5-PACK; BINDER, PERINEAL

Model Number	CB-1000
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using blower mister, when the co2 blower was used on the anastomosis site to remove blood and secure a field of vision, 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 the anastomosis, so the surgery was completed successfully.After confirming the defect in the product, a new product was used and the surgery was successfully completed.The procedure delayed by about 20-30 minutes.
Additional Manufacturer Narrative
Tw # (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
N/a.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 01/21/2025.An investigation was conducted on 2/25/2025.An visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact 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 functional test was performed.Reference braided tubing was connected to a regulated source of co2, not exceeding 50 psi (344 kpa).The flow was adjusted to 5 l/min (0.08 l/s).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 flow was adjusted to 1¿5 (ml/min) using the roller clamp on the iv tubing.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.Based on the returned condition of the device as well as the evaluation results, the reported failure "improper flow or infusion" was not confirmed.The lot # 96255755 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: BINDER, PERINEAL
• 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: 21351446
• Report Number: 2242352-2025-0000123
• Device Sequence Number: 18101854
• Product Code: FQK
• UDI-Device Identifier: 00607567700741
• UDI-Public: (01)00607567700741(10)96255755(17)251031
• 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): 04/03/2025

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: 10/31/2025
• Device Model Number: CB-1000
• Device Catalogue Number: CB-1000
• Device Lot Number: 96255755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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