MAUDE Adverse Event Report: MEDTRONIC MEXICO ONE SOURCE PACK ATLS02; APPARATUS, AUTOTRANSFUSION

Model Number	ATLS02
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a atls02, it was reported that it cracked during the washing process.Blood/water leaked out of the bowl and drain out from the autolog machine onto the floor.The device was replaced to complete the procedure.There was no patient impact associated with this event.Medtronic received additional information that there were audible abnormalities, strange and noisy sound when processing.The leak o ccurred during the wash cycle.The bowl was re-seated to the same machine, the device was still leaking and the bowl cracked.The customer changed to a new set of consumables.The level of reservoir was 1600ml, holding 200ml, saline 2000ml and waste bag was 2000ml.No error warning massage appeared.Patient blood loss as a result of this leak was 300ml.No transfusion was required as a result of this leak.
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.

• Brand Name: ONE SOURCE PACK ATLS02
• 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: 20788523
• Report Number: 9612164-2024-05564
• Device Sequence Number: 6833733
• Product Code: CAC
• UDI-Device Identifier: 00643169108332
• UDI-Public: 00643169108332
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: 07/01/2024
• Device Model Number: ATLS02
• Device Catalogue Number: ATLS02
• Device Lot Number: 0225209511
• 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: 02/01/2023
• Initial Report FDA Received Date: 11/26/2024
• Date Device Manufactured: 06/23/2022
• 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