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

Model Number	CB-1000
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id# (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, blower mister, 5-pack are coming bent out of the sleeve.New device used to complete the procedure.No delay.No harm.
Additional Manufacturer Narrative
Tw # (b)(4).The device was returned to the factory for evaluation on 11/19/2024.An investigation was conducted on 11/26/2024.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 mister device.The device was returned outside the product packaging.The malleable shaft was observed to curved.The malleable shaft was manipulated to straighten with no visual defects observed.The tubing was observed to be cut just below the base of the blower mister handle.No visual defects were observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "material twisted/ bent" was not confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 96255759 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.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
N/a.

• 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: 20662613
• Report Number: 2242352-2024-0001225
• Device Sequence Number: 12813948
• Product Code: FQH
• UDI-Device Identifier: 00607567700741
• UDI-Public: (01)00607567700741(10)96255759(17)251231
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 12/31/2025
• Device Model Number: CB-1000
• Device Catalogue Number: CB-1000
• Device Lot Number: 96255759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2024
• 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