MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC ACROBAT-I POSITIONER; CLAMP-LESS BEATING HEART

Model Number XP-5000

Device Problem Suction Problem (2170)

Patient Problem Hematoma (1884)

Event Date 06/27/2013

Event Type  Injury  

Event Description

The hospital reported that while using acrobat-i positioner, in almost all cases, they have noticed that the device causes a pericardial hematoma while using 200 mmhg pressure.The surgeon experienced similar hematomas in a couple of surgeries and pressed it with gauze and there was no adverse consequences.However the surgeon is worried about using the positioner in very sick patients with a tender myocardium because of this incident.

Manufacturer Narrative

Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standards sop's, all events are tracked and trended to determine whether or not any trends develop.(b)(4).

• Brand Name: ACROBAT-I POSITIONER
• Type of Device: CLAMP-LESS 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 ; 9737097265
• MDR Report Key: 4195967
• MDR Text Key: 5152411
• Report Number: 2242352-2014-01123
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XP-5000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 76