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	Insufficient Information (4580)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Tw id# (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, blower mister, 5-pack (co2 + flushing system) during bypass surgery, the infusion bag in the pressure bag "exploded".Water spread throughout the operating room, over the surgical area and presumably also into the open thorax.It is not clear whether too much pressure on the pressure bag and/or a defect in the infusion bag were the cause.No serious consequences.All necessary and possible antisepsis measures were taken intraoperatively (administration of antibiotics through anesthesia, replacement of materials, surgical gowns and gloves).Cleaning of wet surfaces.No delay.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, blower mister, 5-pack (co2 + flushing system) during bypass surgery, the infusion bag in the pressure bag "exploded".Water spread throughout the operating room, over the surgical area and presumably also into the open thorax.It is not clear whether too much pressure on the pressure bag and/or a defect in the infusion bag were the cause.No serious consequences.All necessary and possible antisepsis measures were taken intraoperatively (administration of antibiotics through anesthesia, replacement of materials, surgical gowns and gloves).Cleaning of wet surfaces.There was a delay.
Additional Manufacturer Narrative
Tw # (b)(4).
Additional Manufacturer Narrative
Tw # (b)(4).A lot history record review was completed for lots 96255740, 96255736, and 96255732 the last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last 3 lots shipped to the account.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, blower mister, 5-pack (co2 + flushing system) during bypass surgery, the infusion bag in the pressure bag "exploded".Water spread throughout the operating room, over the surgical area and presumably also into the open thorax.It is not clear whether too much pressure on the pressure bag and/or a defect in the infusion bag were the cause.No serious consequences.All necessary and possible antisepsis measures were taken intraoperatively (administration of antibiotics through anesthesia, replacement of materials, surgical gowns and gloves).Cleaning of wet surfaces.There was a delay.

• 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: 20374193
• Report Number: 2242352-2024-0001103
• Device Sequence Number: 6868927
• Product Code: FQH
• UDI-Device Identifier: 00607567700741
• UDI-Public: 00607567700741
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C-CB.-1000
• Device Catalogue Number: C-CB.-1000
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 12/18/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/26/2024; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown