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

Model Number	BLOWER MISTER, 5-PACK
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related to tw 685695.The hospital reported that the blower mister used for the coronary artery bypass procedure had creases in the flow of the catheter, and the liquid cannot pass smoothly.The procedure was completed with a new device.No harm to the patient.
Additional Manufacturer Narrative
Trackwise id (b)(6).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
Trackwise id (b)(4).Specific actions for the reported/analyzed failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.The device was returned to the factory for evaluation on 09/26/2022.An investigation was conducted on 09/19/2023.A visual inspection was conducted.Signs of clinical use and light evidence of blood were observed on the device.The flow volume controller was observed to be missing from the hand piece and was not returned for evaluation.The spike chamber was returned filled with saline.A microscopic evaluation was conducted.The flow path through the y-connector was observed to be clear.The glue connecting the shaft connecter and tubing was observed to be placed correctly.No occlusions caused by the glue were observed.The tip of the blower mister was observed to be intact with no visual defects observed.A functional test was performed.Reference braided tubing was connected to a regulated source of co2, not exceeding 50 psi (344 kpa).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 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, however the flow rate was not able to be adjusted due to the missing flow volume controller.Based on the returned condition of the device, the reported failure "flow problem" was not confirmed.The certificate of conformance (c of c) was reviewed.Maquet 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 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: 15509750
• Report Number: 2242352-2022-00818
• Device Sequence Number: 5843823
• 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): 09/22/2023

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: CB-1000
• Device Lot Number: 96255682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 09/26/2023
• 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 Sex: Unknown