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

Model Number BLOWER MISTER, 5-PACK

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Event Description

The hospital reported that during a coronary artery bypass procedure, blower mister clear plastic tip was not on the end when the product was opened.It was not usable and wouldn't work.

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 Description

The hospital reported that during a coronary artery bypass procedure, blower mister clear plastic tip was not on the end when the product was opened.It was not usable and wouldn't work.Surgery was completed with no harm to patient.

Manufacturer Narrative

(b)(4).Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun.".

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure mode.Historical data analysis: (4109/213/67)the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct 2019 through sept 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device (10/13 & 22) enter investigation findings: the device was returned to the factory for evaluation on 03/03/2022.An investigation was conducted on 03/09/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The tip of the blower mister was not observed during the investigation.No other visual defects were observed.Based on the returned condition of the device, the reported failure "component missing" was confirmed.

• Brand Name: BLOWER MISTER, 5-PACK
• Type of Device: 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: 13476556
• MDR Text Key: 287824593
• Report Number: 2242352-2022-00109
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00607567700741
• UDI-Public: 00607567700741
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: BLOWER MISTER, 5-PACK
• Device Catalogue Number: C-CB-1000
• Device Lot Number: 96255671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1