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

Model Number ATL2001

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of an autolog wash kit, the customer reported that the cell saver bowl leaked.The device was replaced to complete the procedure.There was no patient impact associated with this event.Medtronic received additional information that there were no damage noted in the instrument or the disposable.There were no visual, audible, or performance abnormalities.The leak occurred out of the top of the bowl.The leak occurred during 1st spin, customer reported ¿leaked right away¿.The bowl was replaced and new bowl performed adequately.The fill (fluid) level during 1st spin was >500 in reservoir, full saline bags and little to no volume in waste bag.The were no error warning message noted.The patient lost 1 bowl 150 cc of blood as a result of this leak.

Manufacturer Narrative

Additional information: medtronic received additional information that the customer does not believe this incident was directly related to a transfusion.Device evaluation summary: visual inspection shows fin damage.Additional visual inspection shows no straw or dimple plate damage.T here were no signs of holes or cracks observed.Visual analysis of the returned device with fin damage is a representative failure mechanism of bowl lift/leaking.The lid was stuck to the bowl, the lid was separated from the bowl in order to test the device.The bowl was run a couple of times using di water.During the runs there was no bowl lift, leaks or pump speed error messages noted.Conclusion: reason for return was visually confirmed with evidence of fin damage noted but could not be duplicated in the lab.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.

Manufacturer Narrative

Conclusion: the complaint is confirmed.The analysis found fin damage.Additional visual inspection showed no straw or dimple plate damage.There were no signs of holes or cracks observed.Fin damage is a representative failure mechanism of bowl lift/leaking.There are several factors that can contribute to fin damage such as pump speed errors, centrifuge issues, improper kit instalment, and incorrect disposable component dimensions.Fin damage is the result of the bowl contacting the lid.The design of the autolog requires the tubing and lid to remain stationary while the bowl spins at high rpms.The wash kit must be secured in place to ensure proper movement of the centrifuge.Therefore, correct bowl position and fit to the autolog equipment is critical to operation.Trends for issues with this device are monitored.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
• Type of Device: 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: 13771777
• MDR Text Key: 289220767
• Report Number: 9612164-2022-01021
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2023
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 222412607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1