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

Model Number	ACROBAT-I POSITIONER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure acrobat-i positioner nozzle was idling and they could not fix it.After several trials, it was not fixed in the same way, and finally a substitute was issued and the case was successfully completed.The hospital did not report any patient effects.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure acrobat-i positioner nozzle was idling and they could not fix it.After several trials, it was not fixed in the same way, and finally a substitute was issued and the case was successfully completed.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated section: g4, g7, h2, h6, h10.Corrected section: h3- changed to "device not returned¿ h6- changed to "device not returned¿ there were ncmrs , rework, or deviations documented for the reported lot number.[nmcr- 17005- viable airborne particulate for air location #10 at the beating heart manufacturing area (blade/xpose).Based on the dhr/lhr review results, it was determined that there is is no relation between the batch manufacturing process and the reported failure h3 other text : device not returned.

• Brand Name: ACROBAT-I POSITIONER
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10515317
• Report Number: 2242352-2020-00780
• Device Sequence Number: 2445274
• Product Code: MWS
• UDI-Device Identifier: 00607567700574
• UDI-Public: 00607567700574
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2021
• Device Model Number: ACROBAT-I POSITIONER
• Device Catalogue Number: XP-5000
• Device Lot Number: 25149209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1