MAUDE Adverse Event Report: MEDTRONIC MEXICO AUTOLOG WASH KIT; APPARATUS, AUTOTRANSFUSION

Model Number	ATL2001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of an autolog wash kit, it was reported that while using the self-collection instrument, the blood in the centrifugal bowl seemed to be thin.Afterwards, the blood leaked completely from the bowl and could not be used.The autolog instrument was also full of blood, therefore, it was replaced with a different instrument urgently.The patient was treated quickly and no health damage occurred. the autolog wash kit was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the customer was not able to confirm if there was any damage noted in the instrument or the wash kit.The customer could not tell if there were any visual abnormalities, there were no abnormal sounds.The leak occurred at the timing of the first enrichment.The wash kit was not been reseated.When the customer removed the wash kit, the blood was leaking quite a bit, so another company's product was used.The customer was not sure what the fill (fluid) level of the reservoir, holding, saline, and waste bag were at the time of the issue.An error warning message did not appear.Patient blood loss was approximately 200cc at most.An unplanned blood transfusion was not required as a result of thisleak.The customer stated that the instrument will be replaced in the future.The patient was using the autolog while on anti-coagulants.
Additional Manufacturer Narrative
Section e initial reporter: the initial reporter's first and last name and phone number are not available due to regional privacy laws.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.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the bowl and two 2¿-inch tubing stub shows no abnormalities which may have contributed to the reported incident.The bowl was connected to a wash kit tubing set and was run a couple times using di water with no leaks observed.Reason for the return was not confirmed.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.

• Brand Name: AUTOLOG WASH KIT
• 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: 20693732
• Report Number: 9612164-2024-05309
• Device Sequence Number: 7196877
• Product Code: CAC
• UDI-Device Identifier: 00673978521862
• UDI-Public: 00673978521862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/18/2024

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: 05/14/2025
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 226922739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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