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

Model Number	ATLS24
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/28/2023
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.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 use of an autolog one source pack, it was reported the device suffered a fracture in one of its components during surgery.The defective component that fractured was the bell/centrifugal bowl that performs the centrifugal washing, causing the blood to be dislodged.The device was not used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the leak occurred during the filling of the centrifugal bowl.It seemed that all the blood was being discarded to the waste bag.The perfusionist tried to check that it was in correct position and then the blood began to leak out of the centrifugal bowl because it was broken.The bowl was re-seated.There were no changes noted.There was 800 ml of blood in the reservoir, and it was first cycle.There was approximately 800 ml of blood lost with 25% of hct from the bypass machine and another 300 ml from the patient bleeding.There was no error warning message that appeared.The customer does not know for sure if a transfusion will be required.It is presumed that the patient might receive some blood in the icu.Medtronic received additional information that the spilled blood was cleaned and no other device was used.

• 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: 20724677
• Report Number: 9612164-2024-05402
• Device Sequence Number: 11725158
• Product Code: CAC
• UDI-Device Identifier: 00643169108363
• UDI-Public: 00643169108363
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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: 02/11/2025
• Device Model Number: ATLS24
• Device Catalogue Number: ATLS24
• Device Lot Number: 0226489116
• 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: 06/29/2023
• Initial Report FDA Received Date: 11/19/2024
• 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 Sex: Unknown