MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AUTOLOG ONE SOURCE PACK; APPARATUS, AUTOTRANSFUSION

Model Number	ATLS24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that during use of this autolog one source pack, it was reported that once the red blood cells were rescued and after the start of the transfusion, the equipment used for the transfusion showed clots in the filter, this situation was repeated several times with different transfusion equipment, the customer considered that the situation derived from the rescued blood components.The device was used to complete the procedure.There was no patient impact associated with this event.  it was also reported that 3875 milliliters were processed, of which 1785 ml was recovered, four units of red blood cells were washed with a total volume of 1160 ml, 6 bags of 1000 ml was used to wash the bowl, and 800 milliliter's of heparinized solution in total.The surgical time was six hours approximately.During this surgery seven units of fresh frozen plasma were transfused and one platelet apheresis was performed.The cold ischemia time was 6 hours 41 minutes and the warm ischemia time was 33 minutes.The patient was undergoing a liver transplant.

• Brand Name: AUTOLOG ONE SOURCE PACK
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21197068
• Report Number: 9617601-2025-00094
• Device Sequence Number: 15564100
• Product Code: CAC
• UDI-Device Identifier: 00643169108363
• UDI-Public: 00643169108363
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/21/2025

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: 09/11/2023
• Device Model Number: ATLS24
• Device Catalogue Number: ATLS24
• Device Lot Number: 0224544371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 53 YR
• Patient Sex: Unknown
• Patient Weight: 91 KG