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

Model Number	ACROBAT-I POSITIONER
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, acrobat-i positioner suction cup was not working, while the surgeon placed the cup on the apex of heart.They checked the function of suction end on the wall, and that's not malfunction.After the surgeon used another xp-5000, it's working and made the operation proceed.The patient was fine, since the surgeon changed a new one while finding it's not working.The surgeon used om-10000 with xp-5000 together in this operation.
Additional Manufacturer Narrative
Trackwise id#: (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 01/18/2022.An investigation was conduced on 08/31/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the device.There were no visual defects observed on the device.A suction/vacuum strength test was performed per instructions of the vacuum leak test (mcv00001178 rev.A), using calibrated vacuum weight tlt (id: 14272; 2 lbs; due 31-mar-2023) and calibrated pressure gauge (id: 14275; due 30-apr-2023).The device passed the vacuum leak test, good vacuum was obtained and the baffle head was able to lift the weight.Based on the returned condition of the device and the results of the investigation the reported failure "suction failure" was not confirmed.The lot#: 25154457 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.
Event or Problem Description
N/a.

• Brand Name: ACROBAT-I POSITIONER
• Common Device Name: 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: 13387368
• Report Number: 2242352-2022-00093
• Device Sequence Number: 4935768
• Product Code: MWS
• UDI-Device Identifier: 00607567700574
• UDI-Public: 00607567700574
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 10/28/2022
• Device Model Number: ACROBAT-I POSITIONER
• Device Catalogue Number: C-XP-5000
• Device Lot Number: 25154457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OM-10000.
• Patient Sex: Unknown