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

Model Number	ACROBAT-I POSITIONER
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The hospital reported that they ordered 5 kits of acrobat positioners and 1 of 5 was expired when delivered.Kit was opened but not used in case.Staff recognized discolored tubing and checked date on packaging.Kit had been expired for nearly a year.Second kit was opened and the case was completed without issue.No patient involvement.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaint was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period jul 2019 through jun 2021 was reviewed.Run rule was triggered for the month of jun 2021.The trigger is addressed under crf 502712.The crf is currently closed.Testing of actual/suspected device: (10/213/67) the device was returned to the factory for evaluation on 06/16/2021.An investigation was conducted on 06/23/2021.A visual inspection was conducted.The device was returned inside the outer packaging.The device was removed from the outer packaging.The individual package containing the device was observed to be intact.No visible damage was observed.The expiration date on the package read 2020-07-17.A request for the purchase order was sent.The package containing the device was shipped on 9/10/2018, well before the expiration date on the product.(please see attached email).Based on the returned condition of the device, and the information the reported failure "manufacturing, packaging or shipping problem" was not confirmed.

• Brand Name: ACROBAT-I POSITIONER
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 12046958
• Report Number: 2242352-2021-00497
• Device Sequence Number: 11619931
• Product Code: MWS
• UDI-Device Identifier: 00607567700574
• UDI-Public: 00607567700574
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 07/17/2020
• Device Model Number: ACROBAT-I POSITIONER
• Device Catalogue Number: XP-5000
• Device Lot Number: 25140303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/20/2021
• Patient Sequence Number: 1