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

Model Number	ATL2001
Medical Device Problem Codes	Device Alarm System (1012); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during use of an autolog wash kit, the customer reported that an alarm rang during automatic cleaning mode of the instrument.The instrument was then checked and it was noted that the collected blood had leaked from around the bowl.It was confirmed that the blood had also flowed from under the autolog instrument, so the cleaning was stopped.Another autolog instrument was available, so disposable settings was performed without any issue.There was no additional patient impact associated with this event.  the customer stated that the self-blood collection was discarded (approximately 200 cc).The patient was given a blood transfusion of 576 ml.Medtronic received additional information that the physician heard an abnormal sound when the machine was set to ready mode and there was blood found to be leaking from the bottom.The reason for blood leak is unknown.The customer replaced the disposable wash kit in addition to the instrument after the issue occurred.The physician attached a new disposable to another autolog machine available in the hospital and used it.No issue with the autolog instrument was reported.Around half the amount of blood in the washing bowl was leaking on to the floor.Transfusion was performed as usual but it wasn't required particularly due to the leak as the blood loss was within the normal range.The customer did not notice any damage to the autolog wash kit.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed fin damage.Additional visual inspection showed no straw or dimple plate damage.There were no signs of holes or cracks observed.This is representative of failure mechanism of bowl lift/leaking.The bowl was run a couple of times using saline.During the runs there was no bowl lift, leaks or pump speed error messages noted.Reason for return was visually confirmed with evidence of fin damage noted but could not be duplicated in the lab.The cause for the complaint could not be confirmed.Medtronic will continue to monitor for future occurrences and trends per trend analysis procedure.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic received additional information that there was no particular amount of blood planned to be returned, and once a certain amount of washed blood was collected in the collection bag, it was planned to be returned to the patient.However, the self-blood collection (approximately 200 cc) of blood was confirmed to have been discarded.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
This report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 15892584
• Report Number: 9612164-2022-04520
• Device Sequence Number: 6793655
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 224583137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 01/27/2023; 01/09/2024
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/22/2022; 02/24/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 34 KG