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

Model Number ATL2001

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2021

Event Type  malfunction  

Event Description

Medtronic received information that during use of the autolog wash kit and el reservoir at the end of a dissection case clots were observed in the holding bag.Blood collection on the autolog iq instrument was started at 10am till 4pm on the day of the procedure.At the end of the case, clots were noted in the holding bag and the red cell were discarded. approximately 400 ml of blood was discarded as a result of this issue.The patient required a blood transfusion as a result of the discarded blood.In total 900 ml anticoagulant (heparin in saline) was used for a total of 3.6l collected in the reservoir (unknown amount of irrigation fluid).During the case, bio-glue and fibrillar and surgicel were used but they were not used when the cell saver sucker was used to aspirate fluid.Tachosil was used half way through the case and the customer stated that maybe the cell saver sucker was used at the same time.Vitamin k was given pre-bypass and post-bypass prothrombinex, fibrogen concentrate and platelets were given at the head end.Protamine was given at 3.50pm.The collected red cells were looked at in the holding bag at the end of the case.The perfusionist stated that this is not the first time clots have been noticed in the holding bag during a dissection case.The perfusionist thinks this has occurred during a dissection case 5 times previous to this event.None of the prior events were reported and the collected blood was discarded and not given to the patient.Additional information: no clots was observed in the el reservoir.The act values for the case were above 500 when heparinised.Unknown pre and post bypass.The perfusion records were requested but not available.The individual event dates and lot numbers were requested but not available for the additional occurrences.

Manufacturer Narrative

This report is for the 5 previous events reported by the customer.However, individual details of each event are not available, so all occurrences have been included in this report.Conclusion: medtronic cannot confirm or deny the complaint of clots as no product has been returned to date.After evaluation the cause of this complaint could not be determined; additional information is needed; however, this issue could be related to the anticoagulant protocol used, not the manufacturing of the product.The device history record was not reviewed as there is no evidence of manufacturing issues with the device.Complaints received from sep 2020 through sep 2021 for the same failure mode were reviewed and showed no trends warranting escalation related to this occurrence.There were no adverse patient effects as a result of this incidence.Medtronic will continue to monitor for future occurrences and trends.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.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: 16961901
• MDR Text Key: 315844444
• Report Number: 9612164-2023-02125
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2021
• 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