MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC ACROBAT SUV VACUUM STABILIZER SYSTEM, ST; CLAMPLESS BEATING HEART

Model Number OM-9000S

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2014

Event Type  malfunction  

Event Description

The hosp reported that during a coronary artery bypass procedure the blades were missing from the acrobat suv vacuum stabilizer system.A replacement device was used to complete the procedure.The hosp did not report any pt effects.

Manufacturer Narrative

Since the device is not available to be returned to us, a tech eval cannot be performed.Per our standard sop's, call events are tracked and trended to determine whether or not any trends develop.A lot history record could not be performed as the product lot number is unk.(b)(4).

• Brand Name: ACROBAT SUV VACUUM STABILIZER SYSTEM, ST
• Type of Device: CLAMPLESS BEATING HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097690
• MDR Report Key: 3829991
• MDR Text Key: 4447149
• Report Number: 2242352-2014-00253
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OM-9000S
• Device Lot Number: 25086330195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1