MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC BLOWER MISTER, 5-PACK; LAVAGE, JET

Model Number	CB-1000
Medical Device Problem Codes	Backflow (1064); Burst Container or Vessel (1074); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event site name exceeds character limitations: (b)(6).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 , they have been experiencing regular problems with blower mister, 5-pack: the blower mister directs part of the co2 into the bag of physiological saline solution, such that the bag ¿explodes¿ after some time.The surgeon was forced to install a new one during the same operation.There was no delay.There was no patient harm.

• 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: 24796855
• Report Number: 2242352-2026-0000250
• Device Sequence Number: 10706913
• Product Code: FQH
• UDI-Device Identifier: 00607567700741
• UDI-Public: (01)00607567700741(10)96255799(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/06/2026

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 Model Number: CB-1000
• Device Catalogue Number: CB-1000
• Device Lot Number: 96255799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2026
• 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