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

Model Number	BLOWER MISTER, 5-PACK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
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 before the procedure, a blower mister used for a coronary artery bypass connector falls off.Replacement with a new device was used to complete surgery.No harm to patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 12/01/2022.An investigation was conducted on 12/14/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the tubing of the device.There were no visual defects observed on the blower mister.The connector was observed to be intact with no visual defects observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "break;connector" 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 #96255682 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.

• Brand Name: BLOWER MISTER, 5-PACK
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 15887593
• Report Number: 2242352-2022-00983
• Device Sequence Number: 17471924
• Product Code: FQH
• UDI-Device Identifier: 00607567700741
• UDI-Public: 00607567700741
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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: 06/30/2023
• Device Model Number: BLOWER MISTER, 5-PACK
• Device Catalogue Number: C-CB-1000
• Device Lot Number: 96255682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 51 KG