MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC ACROBAT-I STABILIZER; CLAMPLESS BEATING HEART

Model Number OM-10000

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2014

Event Type  malfunction  

Event Description

The hosp reported that during preparation for the surgery set up for a coronary artery bypass procedure, when the acrobat-i stabilizer was opened there was no stabilizer inside the box, only the tubing and blade.A replacement device was used to complete the procedure.The hosp did not report any pt effects.

Manufacturer Narrative

The device has not yet been returned to maquet cardiac surgery for eval.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.A lot history record review was completed for the reported product lot number.There was no non-conformance records in the lot history.Internal complaint no: (b)(4).

• Brand Name: ACROBAT-I STABILIZER
• 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: 3919674
• MDR Text Key: 19585235
• Report Number: 2242352-2014-00640
• 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: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: OM-10000
• Device Lot Number: 25081443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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