MAUDE Adverse Event Report: MEDTRONIC MEXICO AUTOLOG ONE SOURCE PACK; APPARATUS, AUTOTRANSFUSION

Model Number	ATLS24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the bowl, no manifold and tubing, shows no outward signs of damage or abnormalities.No fin, straw, or dimple plate damage was noted, no signs of holes or cracks were detected.The bowl was run a couple of times using di water.During the runs there was no bowl lift, leaks or pump speed error messages noted.Reason for return was not confirmed.This regulatory report is being submitted due to retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that during priming of this autolog one source pack, it was reported that the kit was connected to the instrument normally.After priming, the bowl started leaking saline.There was no blood loss as the leakage was noticed before the machine was used.The device was replaced to complete the procedure.There was no patient involvement, so no adverse effect occurred.Additionally, the customer confirmed that there was no damage made to the bowl by their team.Medtronic received additional information that there were no visual, audible or performance abnormalities.The leak/spill on the disposable specifically occurred at bowl.The fluid level of the reservoir, holding, saline and waste bag at the time of the issue is not known.The machine showed the alarm message just when the saline ran in the bowl.After the error warning message, the kit was changed.The machine worked well after the kit was changed.There was no blood loss as a result of this leak.There was no transfusion required as a result of this leak.

• Brand Name: AUTOLOG ONE SOURCE PACK
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20784811
• Report Number: 9612164-2024-05553
• Device Sequence Number: 5068931
• Product Code: CAC
• UDI-Device Identifier: 00643169108363
• UDI-Public: 00643169108363
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K093535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 03/18/2024
• Device Model Number: ATLS24
• Device Catalogue Number: ATLS24
• Device Lot Number: 0224584629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2022
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown