MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACROBAT SUV STABILIZER; STABILIZER, HEART

Model Number OM-9000Z

Device Problems Mechanical Problem (1384); Suction Failure (4039)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

Trackwise 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.H3 other text : device not returned.

Event Description

The hospital reported that during a coronary artery bypass procedure using acrobat suv stabilizer system om-9000z, they tried to fix it to the anastomosis site of the coronary artery, but it could not be fixed because the suction pressure was minus 400mmhg.It did not adsorb.It is considered that there was a problem with the suction.Swivel is no problem.The retractor lock was fine.Surgery was completed using the new om-9000z.No procedural delay.There were no effects on patients.

Manufacturer Narrative

Trackwise # (b)(4).The lot # 3000269996 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.

Manufacturer Narrative

(b)(4).Corrected sections: h6--problem code corrected from "1384" to "4039".

Event Description

N/a.

• Brand Name: ACROBAT SUV STABILIZER
• Type of Device: STABILIZER, HEART
• 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: 17438904
• MDR Text Key: 320784158
• Report Number: 2242352-2023-00646
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: 00607567900004
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OM-9000Z
• Device Catalogue Number: OM-9000Z
• Device Lot Number: 3000269996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1