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

Model Number	ATLS24
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the complaint device was not returned.Visual inspection of the unopened device showed 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 deionized water.During the runs there was no bowl lift, leaks or pump speed error messages noted.The 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 use of an autolog one source pack, it was reported that during blood washing, a lot of red blood cells were ejected to the waste bag.The maintenance of the autolog iq was done without issue, so the customer thought that maybe the tubing of the one source pack was faulty.The device was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that there was no damage noted in the one source pack.There were no visual, audible, or performance abnormalities.The issue occurred during the first washing cycle.The customer reinstalled the tubing, nothing changed for the next washing cycle.The customer stated that they saw that, the color of the waste bag was more red than usual and thought that more red cells had gone in the waste bag.There was no error message.A transfusion was not required as a result of this issue.

• 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: 20743874
• Report Number: 9612164-2024-05446
• Device Sequence Number: 8649261
• Product Code: CAC
• UDI-Device Identifier: 00643169108363
• UDI-Public: 00643169108363
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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: Other
• Device Expiration Date: 05/21/2025
• Device Model Number: ATLS24
• Device Catalogue Number: ATLS24
• Device Lot Number: 0227313674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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